FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Biatain Soft-Hold
DI: 05708932475723
·
Model: 3473
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Biatain Soft-Hold
- Primary DI
- 05708932475723
- Version / Model
- 3473
- Catalog Number
- 3473
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-30
- Public Version
- 2
- Public Version Date
- 2024-07-12
- Public Version Status
- Update
- Public Device Record Key
- c71bbf86-4588-401d-80df-7cf2c3312caa
- Distribution End Date
- 2024-07-10
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NAD | Dressing, wound, occlusive | General, Plastic Surgery | 878.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44970 | Exudate-absorbent dressing, non-gel, non-antimicrobial | A wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05708932442756 | GS1 | Retail Box | 5 | Not in Commercial Distribution | 2024-07-10 |
| Primary | 05708932475723 | GS1 | ||||
| Package | 05708932442763 | GS1 | Shipper Box | 32 | Not in Commercial Distribution | 2024-07-10 |
Customer Contacts
- Phone
- +1(800)533-0464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 2 | Inch | |
| Length | 7 | Centimeter | |
| Length | 3 | Inch | |
| Device Size Text, specify | Dressing Shape Rectangular | ||
| Width | 5 | Centimeter |