Identity
- Trade Name
- Coloplast FDA UDI
- Generic Name
- Peristomal/periwound dressing FDA UDI
- Device Name
- Coloplast Paste. Fills in cavities/folds. Ostomy Care. 2 oz. / 60 g FDA UDI
- Model / Reference
- 2650 FDA UDI
- Description
- Coloplast Paste. Fills in cavities/folds. Ostomy Care. 2 oz. / 60 g FDA UDI
Identifiers
- Catalog Number
- 2650 FDA UDI
- Primary DI / UDI-DI
- 05708932453004 FDA UDI
- FDA Product Code
- EXB FDA UDI
- GMDN Term
- Peristomal/periwound dressing FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Weight — 60 Gram FDA UDI
Category: Peristomal/periwound dressing
Coloplast by Coloplast A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Peristomal/periwound dressing.
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- cofoe — Cofoe Medical Technology Co., Ltd. · Class I
- Halyard — O&M HALYARD, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Coloplast A/S
Sources (1)
- FDA UDI 14307a01-7588-451e-a6dc-e5c196630e2c 36 fields · synced May 30, 2026