Identity
- Trade Name
- ComPel Single Wrap FDA UDI
- Generic Name
- Sterilization packaging, reusable FDA UDI
- Device Name
- COMPEL SINGLE WRAP 36X36 2PLY - 2 PLY MERROWED-CC BLUE THR FDA UDI
- Model / Reference
- 27666302 FDA UDI
- Description
- COMPEL SINGLE WRAP 36X36 2PLY - 2 PLY MERROWED-CC BLUE THR FDA UDI
Identifiers
- Catalog Number
- 27666302 FDA UDI
- Primary DI / UDI-DI
- 00634916016543 FDA UDI
- 510(k) Number
- K923408 FDA UDI
- FDA Product Code
- FRG FDA UDI
- GMDN Term
- Sterilization packaging, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sterilization packaging, reusable
ComPel Single Wrap by Standard Textile Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K923408 also covers:
- ComPel Single Wrap — STANDARD TEXTILE CO., INC.
- ComPel Single Wrap — STANDARD TEXTILE CO., INC.
- ComPel Single Wrap — STANDARD TEXTILE CO., INC.
- ComPel Single Wrap — STANDARD TEXTILE CO., INC.
- ComPel Single Wrap — STANDARD TEXTILE CO., INC.
- ComPel Single Wrap — STANDARD TEXTILE CO., INC.
- ComPel Single Wrap — STANDARD TEXTILE CO., INC.
- ComPel Single Wrap — STANDARD TEXTILE CO., INC.
- ComPel Single Wrap — STANDARD TEXTILE CO., INC.
- ComPel Single Wrap — STANDARD TEXTILE CO., INC.
- ComPel Single Wrap — STANDARD TEXTILE CO., INC.
- ComPel Single Wrap — STANDARD TEXTILE CO., INC.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Standard Textile Co., Inc.
Sources (1)
- FDA UDI 89bd97d5-d50d-4b47-93ae-058d7deb29e7 36 fields · synced May 30, 2026