FDA UDI
In Commercial Distribution
🇺🇸 United States
Biatain Silicone Ag Sacral
DI: 05701780211444
·
Model: 39651
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Biatain Silicone Ag Sacral
- Primary DI
- 05701780211444
- Version / Model
- 39651
- Catalog Number
- 39651
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-30
- Public Version
- 1
- Public Version Date
- 2022-12-08
- Public Version Status
- New
- Public Device Record Key
- aad1f27c-c9cb-4a83-a44b-91a74e5bade9
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- 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 |
|---|---|---|---|---|
| FRO | Dressing, wound, drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48124 | Exudate-absorbent dressing, non-gel, antimicrobial | A wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. The device may be in the form of a flat sheet/film, 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 | 05701780210393 | GS1 | Retail Box | 5 | In Commercial Distribution | |
| Primary | 05701780211444 | GS1 | ||||
| Package | 05701780210409 | GS1 | Shipper Box | 18 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)533-0464
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191536 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Pad Width - in 6.7 | ||
| Width | 25 | Centimeter | |
| Length | 25 | Centimeter | |
| Length | 9.8 | Inch | |
| Device Size Text, specify | Pad Length - in 6.7 | ||
| Device Size Text, specify | Dressing Shape Sacral | ||
| Device Size Text, specify | Pad Length - cm 17 | ||
| Width | 9.8 | Inch | |
| Device Size Text, specify | Pad Width - cm 17 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if package is damaged and consult IFU. Do not resterilize.