TDS Sterify Gel_Rev03_EN

STERIFY GEL

Sterify Gel - polymer hydrogel for the treatment of periodontal disease

0426

Rev 03 01/06/2023

PRODUCT DATA SHEET

INTENDED USE

Sterify Gel is a mucoadhesive polymer hydrogel in a pre-filled syringe for the treatment of periodontal disease.

MEDICAL DEVICE CLASSIFICATION

Annex VIII - MDR 2017/745

Class III, Rule 8

EMDN

P900402 - Resorbable devices for filling and reconstruction

MDS RDM

1105 - Devices in sterile condition

Pending registration 80593888501W4

Basic UDI-DI

MANUFACTURER'S DATA

NAME AND BUSINESS NAME

Sterify S.r.l.

ADDRESS

Via Nizza, 262/1 - 10126 Torino (TO), Italy

TELEPHONE

+39 011 2173 3224

EMAIL

m.fiorini@sterify.it; p.fattori@sterify.it

INTERNET SITE

www.sterify.it

MAIN TECHNICAL FEATURES Pre-filled ready-to-use syringe. Polyvinyl polymer-based gel with high plasticity and mucoadhesivity.

Excipients: Nisin (preservative). Hydroxytyrosol (visco-modulating agent). Magnesium ascorbyl phosphate (gamma-protector). Gel with occluding action of periodontal and peri-implant gingival pockets, it creates an environment unsuitable for bacterial growth and promotes subsequent tissue regeneration. Combined with grafts, it promotes healing of gingival mucosa and bone tissue. High mucoadhesive format available for periodontal and peri-implant lesions with lower containment capacity.

STERILIZATION Device sterilized by gamma irradiation at 25 kGy. SHELF LIFE

The hydrogel based on polyvinyl polymers, nisin, hydroxytyrosol and magnesium ascorbyl phosphate of the Sterify line has a Shelf Life of 3 years from the date of sterilization. Shelf Life is guaranteed only if the devices are in original and undamaged packaging and stored according to the directions provided by Sterify S.r.l.

Sterify S.r.l. Registered Office: Via Nizza, 262/1 - 10126 Torino (TO), Italy

1

Tel: +39 011 2173 3224 - www.sterify.it

STERIFY GEL

Sterify Gel - polymer hydrogel for the treatment of periodontal disease

0426

Rev 03 01/06/2023

PRODUCT DATA SHEET

RESORPTION TIMES Sterify Gel is a resorbable injectable device; its degradation and resorption, in the absence of external factors contributing to its acceleration or delay, depends on the time it takes to be physically removed from the periodontal and peri-implant pockets, on average over 14 to 30 days, so that its subsequent removal at the dental office is unnecessary.

PACKING

Primary

Aluminum/Coupled Envelope (ALU/PE)

Outer packaging

Cardboard box

MAIN COMPONENTS

Polyvinyl polymers

Polyvinyl Alcohol (PVA), Polyvinyl Pyrrolidone (PVP)

Nisin

Preservative, bacteriocin Visco-modulator, anti-oxidant

Hydroxytyrosol

Magnesium ascorbyl phosphate

Gamma-protector, stabilized vitamin C Citrate buffered saline solution (CBS)

Saline solution

DIRECTIONS FOR STORAGE Device should be stored in a cool, dry place at a temperature between 15° and 25°C (room temperature), avoiding exposure to direct sunlight. If stored properly and in intact packaging, the sterility of the device is guaranteed for 3 years from the date of manufacture (see expiration date on the outer label).

DIRECTIONS FOR DISPOSAL

Unused product

Dispose of as non-hazardous hospital waste according to current laws.

Product used

Dispose of as hazardous hospital waste according to current laws. The materials that make up the packaging do not require special disposal conditions.

Packaging materials

FORMATS AND CODES

Code (REF)

Formulation

Format

Pieces

STY-GEL0301

Sterify Gel

0.3 ml

1pcs

STY-GEL0303

Sterify Gel

0.3 ml

3pcs

STY-GEL0501

Sterify Gel

0.5 ml

1pcs

STY-GEL0503

Sterify Gel

3pcs

0.5 ml

STY-GEL1001

Sterify Gel

1pcs

1.0 ml

STY-GEL1003

Sterify Gel

3pcs

1.0 ml

STY-GEL0301HM

Sterify Gel HM

1pcs

0.3 ml

STY-GEL0303HM

Sterify Gel HM

3pcs

0.3 ml

STY-GEL0501HM

Sterify Gel HM

1pcs

0.5 ml

STY-GEL0503HM

Sterify Gel HM

3pcs

0.5 ml

STY-GEL1001HM

Sterify Gel HM

1pcs

1.0 ml

STY-GEL1003HM

Sterify Gel HM

3pcs

1.0 ml

Sterify S.r.l. Registered Office: Via Nizza, 262/1 - 10126 Torino (TO), Italy

2

Tel: +39 011 2173 3224 - www.sterify.it

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