AccessGUDID - DEVICE: GuidOss (08809186541237)

GUDID

Device Identifier (DI) Information

Brand Name: GuidOss
Version or Model: GDS 5-2010
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Nibec Co., Ltd.

Primary DI Number: 08809186541237
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687796909 *Terms of Use

Device Description: GuidOss is made from pure Type I porcine collagen membrane. It is a resorbable collagen membrane for guided tissue and bone regenerations. The Type I collagen is obtained from porcine skin purified to avoid immunological reactions. The GuidOss membrane is manufactured by fibrillogenesis and glycation with sugar (ribose). The collagen fibers are self-assembled by the process of fibrillogenesis. The glycation is a natural process of cross-linking of collagen occurring in vivo. The glycated collagen fibers exhibit increased mechanical strength, thermal stability and increased resistance to pepsin digestion compared to non-glycated collagen.

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 [?]
K133507	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
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 20mm X 10mm

Device Record Status

Public Device Record Key: c143bd6d-3f6f-450f-8e0e-33309a04d648
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016