AccessGUDID - DEVICE: creos™ syntoprotect (07332747181845)

GUDID

Device Identifier (DI) Information

Brand Name: creos™ syntoprotect
Version or Model: N1615TI-13-1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: N1615TI-13-1
Company Name: Nobel Biocare AB

Primary DI Number: 07332747181845
Issuing Agency: GS1
Commercial Distribution End Date: January 24, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 353939929 *Terms of Use

Device Description: creos™ syntoprotect Ti-reinforced PTFE membrane 150 No13

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYC	Bone grafting material, synthetic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Lower limit of temperature * 15°C. Upper limit of temperature * 30°C
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 150.000 Micrometer

Device Record Status

Public Device Record Key: d7ce43ef-0f92-4f30-9bc4-00707c1fedf1
Public Version Date: January 25, 2024
Public Version Number: 4
DI Record Publish Date: January 13, 2021