AccessGUDID - DEVICE: STRAUMANN MEMBRAGEL (07630031726834)

GUDID

Device Identifier (DI) Information

Brand Name: STRAUMANN MEMBRAGEL
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 070.102
Company Name: Institut Straumann AG

Primary DI Number: 07630031726834
Issuing Agency: GS1
Commercial Distribution End Date: April 25, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 483599259 *Terms of Use

Device Description: Straumann® MembraGel , Applicator

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?
42630	Hydrogel dental regeneration membrane	A sterile bioabsorbable material intended to be used to aid in dental and maxillofacial bone regeneration (e.g., after periodontal disease, or after tooth loss 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 comprised of synthetic liquid compounds that are mixed to react and form a gel (typically includes syringes and mixing tip); it is applied between soft tissue and bone during guided bone regeneration (GBR), periodontal flap surgery, and guided tissue regeneration (GTR) surgical procedures. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NPK	Barrier, synthetic, intraoral

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082111	000

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: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 169d7a87-2574-44e3-a3c8-b8a9a564bd74
Public Version Date: January 17, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2015