AccessGUDID - DEVICE: SYMBIOS® (EFRIOSNRM12240)

GUDID

Device Identifier (DI) Information

Brand Name: SYMBIOS®
Version or Model: USOSNRM1224
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OSNRM1224
Company Name: Dentsply Implants Manufacturing GmbH

Primary DI Number: EFRIOSNRM12240
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344038836 *Terms of Use

Device Description: OsteoShield® PTFE Non-Resorbable Membrane (12x24mm)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
58502	Pliable-polymer dental regeneration membrane, bioabsorbable, ligated	A sterile 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	true

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: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4ba70b11-8437-4bcd-a7c5-8c795607b675
Public Version Date: December 07, 2020
Public Version Number: 4
DI Record Publish Date: February 03, 2017