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
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
Page 1 Page 2Made with FlippingBook Annual report