FDA UDI
In Commercial Distribution
🇺🇸 United States
Bioseal Inc.
DI: 00630094021034
·
Model: 2103/25
·
BIOSEAL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bioseal Inc.
- Primary DI
- 00630094021034
- Version / Model
- 2103/25
- Company Name
- BIOSEAL
- Labeler DUNS
- 186968939
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-19
- Public Version
- 1
- Public Version Date
- 2023-12-27
- Public Version Status
- New
- Public Device Record Key
- 1738f77a-200b-496d-8306-9e2c654816e8
Device Description
Packing Gauze X-Ray Detectable
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 |
|---|---|---|---|---|
| GDY | Gauze/sponge, internal, x-ray detectable | General, Plastic Surgery | 878.4450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15047 | Gauze packer | A hand-held, surgical instrument used for introducing and packing gauze or dressings into body cavities. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10630094021031 | GS1 | Case | 25 | In Commercial Distribution | |
| Primary | 00630094021034 | GS1 |