AccessGUDID - DEVICE: EpiGuide® Bioresorbable Barrier Matrix (00812337027137)

GUDID

Device Identifier (DI) Information

Brand Name: EpiGuide® Bioresorbable Barrier Matrix
Version or Model: 50600-02
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 50600-02
Company Name: DSM BIOMEDICAL, INC.

Primary DI Number: 00812337027137
Issuing Agency: GS1
Commercial Distribution End Date: May 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 131107757 *Terms of Use

Device Description: No description.

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):	Yes
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?
58503	Pliable-polymer dental regeneration membrane, bioabsorbable, tacked	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 synthetic polymer material that is held in place with bioabsorbable tacks fixed into the jawbone; it is applied between soft tissue and bone during periodontal flap surgery and other guided bone regeneration (GBR) and guided tissue regeneration (GTR) surgical procedures. The tacks and a plasticizer used to temporarily 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 [?]
K940643	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 30 Millimeter
Width: 18 Millimeter

Device Record Status

Public Device Record Key: 8af1275e-65f4-4d42-a9a5-59933e543b61
Public Version Date: June 16, 2023
Public Version Number: 7
DI Record Publish Date: September 04, 2015