FDA UDI
In Commercial Distribution
🇺🇸 United States
BioStrip BioHorizons - 25mm x 75mm x 1mm
DI: 00813909010267
·
Model: BH2210
·
NOVABONE PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- BioStrip BioHorizons - 25mm x 75mm x 1mm
- Primary DI
- 00813909010267
- Version / Model
- BH2210
- Catalog Number
- BH2210
- Company Name
- NOVABONE PRODUCTS, LLC
- Labeler DUNS
- 828813290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 4
- Public Version Date
- 2024-12-16
- Public Version Status
- Update
- Public Device Record Key
- 1ade6c7a-d0cf-4e44-9232-36f369450605
Device Description
Collagen wound dressing
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGN | Dressing, Wound, Collagen | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813909010267 | GS1 | ||||
| Unit of Use | 00813909010540 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142712 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 25 | Millimeter | |
| Depth | 1 | Millimeter | |
| Length | 75 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 40 Degrees Celsius