Identity
- Trade Name
- SRI Healthcare FDA UDI
- Generic Name
- Sterilization packaging, reusable FDA UDI
- Device Name
- Wrapper, 53 x 72, Size Large, Green FDA UDI
- Model / Reference
- WRAP05307200-4-SV-0MDGN-0 FDA UDI
- Description
- Wrapper, 53 x 72, Size Large, Green FDA UDI
Identifiers
- Catalog Number
- 4360 FDA UDI
- Primary DI / UDI-DI
- 00850057346053 FDA UDI
- 510(k) Number
- K931874 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
SRI Healthcare by Elevate Textiles — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Sterilization packaging, reusable.
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- Brasseler USA — Peter Brasseler Holdings, LLC · Class II
- E-Z Jett Cassette — ZIRC DENTAL PRODUCTS, INC. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class II
Cleared under the same submission
K931874 also covers:
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
- Elevate Textiles
Sources (1)
- FDA UDI df220fc8-6eba-4d0f-8dae-be329a01a041 36 fields · synced Jun 8, 2026