AccessGUDID - DEVICE: BioStrip BioHorizons - 25mm x 75mm x 1mm (00813909010267)

GUDID

Device Identifier (DI) Information

Brand Name: BioStrip BioHorizons - 25mm x 75mm x 1mm
Version or Model: BH2210
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BH2210
Company Name: NOVABONE PRODUCTS, LLC

Primary DI Number: 00813909010267
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 828813290 *Terms of Use

Device Description: Collagen wound dressing

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?
47184	General oral wound dressing, animal-derived	A collagen protein matrix derived from animal products (e.g., porcine, bovine) intended to be used as a protective cover for the general oral mucosa to manage wounds and sores in the mouth such as ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds; it may in addition, or alternatively, be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis. It may be supplied in various forms (e.g., gel, paste, fluid, water/oil spray solution) for use in the home or a clinical setting. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGN	Dressing, Wound, Collagen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142712	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: less than 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 25 Millimeter
Depth: 1 Millimeter
Length: 75 Millimeter

Device Record Status

Public Device Record Key: 1ade6c7a-d0cf-4e44-9232-36f369450605
Public Version Date: December 16, 2024
Public Version Number: 4
DI Record Publish Date: September 14, 2016