AccessGUDID - DEVICE: GENOSS Collagen Membrane (08809324764016)

GUDID

Device Identifier (DI) Information

Brand Name: GENOSS Collagen Membrane
Version or Model: GCT1220
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GCT1220
Company Name: GENOSS CO., Ltd.

Primary DI Number: 08809324764016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690083006 *Terms of Use

Device Description: Resorbable Dental Barrier membrane

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 [?]
K102307	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 1 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 12 Millimeter
Length: 20 Millimeter

Device Record Status

Public Device Record Key: c2f11cfa-4a70-48dd-9fee-f3fd769f673a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 09, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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