Identity
- Trade Name
- OPSITE™ FLEXIGRID FDA UDI
- Generic Name
- Synthetic polymer semi-permeable film dressing, adhesive FDA UDI
- Device Name
- Transparent dressing 15cm x 20cm, Carton of 10 Transparent dressing 6in x 8in, Carton of 10 FDA UDI
- Model / Reference
- 4631,66024631 FDA UDI
- Description
- Transparent dressing 15cm x 20cm, Carton of 10 Transparent dressing 6in x 8in, Carton of 10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05000223415433 FDA UDI
- FDA Product Code
- KGX FDA UDI
- GMDN Term
- Synthetic polymer semi-permeable film dressing, adhesive FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
Ethylene Oxide FDA UDI
Category: Synthetic polymer semi-permeable film dressing, adhesive
Opsite™ Flexigrid by Smith & Nephew Medical, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Smith & Nephew Medical, Ltd.
Sources (1)
- FDA UDI f4e70bd3-e1f0-4333-b032-7623ae436f02 33 fields · synced May 30, 2026