creos™ syntoprotect

Basic Information

• Brand Name: creos™ syntoprotect
• Primary DI: 07332747181852
• Version / Model: N162530-1
• Catalog Number: N162530-1
• 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: 3
• Public Version Date: 2024-01-26
• Public Version Status: Update
• Public Device Record Key: af7f51f9-8d26-4ab2-9e38-529fe4f79f16
• Distribution End Date: 2024-01-25

Device Description

creos™ syntoprotect PTFE membrane 200 25 x 30 mm. Also available in a pack of 4 with catalog number N162530-4, as creos™ syntoprotect PTFE membrane 200 25 x 30 mm 4x.

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: Labeling does not contain MRI Safety Information
• 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
Package	17332747181859	GS1	BOX	4	Not in Commercial Distribution	2024-01-25
Primary	07332747181852	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	200.000	Micrometer

Storage Conditions

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