FDA UDI
In Commercial Distribution
🇺🇸 United States
Coloplast
DI: 05708932702942
·
Model: 9500
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Coloplast
- Primary DI
- 05708932702942
- Version / Model
- 9500
- Catalog Number
- 9500
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-25
- Public Version
- 2
- Public Version Date
- 2022-12-06
- Public Version Status
- Update
- Public Device Record Key
- 7eaea620-be40-43e5-86e5-31b77381afad
Device Description
Coloplast Clamp . For drainable ostomy bags.
Device Characteristics
- Single Use
- No
- 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
- MR Safe
- 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 |
|---|---|---|---|---|
| 37502 | Ostomy bag closure device | A device intended to facilitate the emptying and/or reclosure of an open-ended ostomy bag. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00762123001493 | GS1 | Retail Box | 20 | In Commercial Distribution | |
| Primary | 05708932702942 | GS1 | ||||
| Package | 00762123007259 | GS1 | Shipper Box | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)533-0464
- [email protected]