FDA UDI
In Commercial Distribution
🇺🇸 United States
Bioseal Inc.
DI: 00630094044644
·
Model: 4464/20
·
BIOSEAL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bioseal Inc.
- Primary DI
- 00630094044644
- Version / Model
- 4464/20
- Company Name
- BIOSEAL
- Labeler DUNS
- 186968939
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-19
- Public Version
- 1
- Public Version Date
- 2024-01-29
- Public Version Status
- New
- Public Device Record Key
- c862541e-9ad6-43ab-8cbc-65029c1233b7
Device Description
Burn Net Size 7
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAB | Gauze / sponge,nonresorbable for external use | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48128 | Gauze strip, non-antimicrobial | A thin length of non-medicated woven material (e.g., cotton, cellulose) primarily designed to pack draining wounds to absorb exudates; it does not include an antimicrobial agent. It may be soaked with medication (not included) before application. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10630094044641 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00630094044644 | GS1 |