AccessGUDID - DEVICE: THE Cover (08800039003773)

GUDID

Device Identifier (DI) Information

Brand Name: THE Cover
Version or Model: BP3-3040
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PURGO BIOLOGICS Inc.

Primary DI Number: 08800039003773
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687429456 *Terms of Use

Device Description: Repair or replace bone defects around teeth, increase or reconstruct alveolar bone. THE Cover prevents the epithelial cells from migrating to the apical end and prevents the gingival fibers from penetrating the damaged area. THE Cover induces cell proliferation from the periodontal ligament and alveolar bone.

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?
58709	Collagen dental regeneration membrane	A sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and to regenerate bone defects around implants and at sites intended for implant placement, by acting as a barrier to prevent the down-growth of soft tissue into the underlying bone during the healing period. It is a pliable material made of animal-derived collagen (e.g., porcine) which may be fixed to soft tissues with sutures; it is applied between soft tissue and bone during periodontal flap surgery and applied to grafted bone defects in guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NPL	Barrier, Animal Source, Intraoral

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230091	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
No Device Sizes

Device Record Status

Public Device Record Key: b33d4b52-7d32-4b11-8e44-866867de9389
Public Version Date: November 08, 2023
Public Version Number: 1
DI Record Publish Date: October 31, 2023