creos™ syntoprotect

Basic Information

• Brand Name: creos™ syntoprotect
• Primary DI: 07332747181715
• Version / Model: N1625TI-13-1
• Catalog Number: N1625TI-13-1
• Company Name: Nobel Biocare AB
• Labeler DUNS: 353939929
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-13
• Public Version: 4
• Public Version Date: 2024-01-25
• Public Version Status: Update
• Public Device Record Key: 3c4aef9f-9ae8-42f2-9aa2-6382fa16ae17
• Distribution End Date: 2024-01-24

Device Description

creos™ syntoprotect Ti-reinforced PTFE membrane 250 No13

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYC	Bone grafting material, synthetic	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62481	Pliable-polymer dental regeneration membrane, non-bioabsorbable	A sterile non-bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. It is a pliable synthetic polymer material that is held in place between soft tissue and bone [e.g., with ligatures, sutures, or pins (may be attached/included)] and applied during periodontal flap surgery and other guided bone regeneration (GBR) and guided tissue regeneration (GTR) surgical procedures. A plasticizer to soften the membrane may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07332747181715	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Height	250.000	Micrometer

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Lower limit of temperature * 15°C. Upper limit of temperature * 30°C
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius