FDA UDI
In Commercial Distribution
🇺🇸 United States
Brava
DI: 05708932676649
·
Model: 12076
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Brava
- Primary DI
- 05708932676649
- Version / Model
- 12076
- Catalog Number
- 12076
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-08
- Public Version
- 1
- Public Version Date
- 2022-04-18
- Public Version Status
- New
- Public Device Record Key
- 2aee02f9-470e-4f32-a72b-ddaf37efb735
Device Description
Brava Elastic Barrier Strip XL. Supports the rim of the ostomy baseplate
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EXB | COLLECTOR, OSTOMY | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46207 | Peristomal/periwound dressing | A non-sterile substance or material intended to be applied to peristomal and/or periwound skin intended to protect it from body effluent (e.g., faeces, urine, wound exudate) and/or to help secure the seal of a stomal appliance or wound dressing. The device is typically available in a variety of forms including cream, paste in a tube or other applicator, paste in ready formed strips, 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 | 05708932676663 | GS1 | Shipper Box | 16 | In Commercial Distribution | |
| Package | 05708932676656 | GS1 | Retail Box | 30 | In Commercial Distribution | |
| Primary | 05708932676649 | GS1 |
Customer Contacts
- Phone
- +1(800)533-0464
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight.