Identity
- Trade Name
- Standard Supreme Wrapper FDA UDI
- Generic Name
- Sterilization packaging, reusable FDA UDI
- Device Name
- WRAPPER STANDARD SUPREME MTY 45X45 2PLY - MERROWED W/WHITE THREAD FDA UDI
- Model / Reference
- 21525002 FDA UDI
- Description
- WRAPPER STANDARD SUPREME MTY 45X45 2PLY - MERROWED W/WHITE THREAD FDA UDI
Identifiers
- Catalog Number
- 21525002 FDA UDI
- Primary DI / UDI-DI
- 00634916000610 FDA UDI
- 510(k) Number
- K172207 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
Moist Heat or Steam Sterilization FDA UDI
Category: Sterilization packaging, reusable
Standard Supreme Wrapper 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
K172207 also covers:
- Standard Supreme Surgical Wrapper — STANDARD TEXTILE CO., INC.
- Standard Supreme Wrapper — STANDARD TEXTILE CO., INC.
- Standard Supreme Wrapper — STANDARD TEXTILE CO., INC.
- Standard Supreme Wrapper — STANDARD TEXTILE CO., INC.
- Standard Supreme Wrapper — STANDARD TEXTILE CO., INC.
- Standard Supreme Wrapper — STANDARD TEXTILE CO., INC.
- Standard Supreme Wrapper — STANDARD TEXTILE CO., INC.
- Standard Supreme Wrapper — STANDARD TEXTILE CO., INC.
- Standard Supreme Wrapper — STANDARD TEXTILE CO., INC.
- Standard Supreme Wrapper — STANDARD TEXTILE CO., INC.
- Standard Supreme Wrapper — STANDARD TEXTILE CO., INC.
- Standard Supreme Wrapper — 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 45dfe9a7-aba1-4389-96d6-717fb84ed360 36 fields · synced Jun 6, 2026