Identity
- Trade Name
- SRI Healthcare FDA UDI
- Generic Name
- Surgical gown, reusable FDA UDI
- Device Name
- Gown, Compel L3 LG, 24-Pk NS FDA UDI
- Model / Reference
- 8603 FDA UDI
- Description
- Gown, Compel L3 LG, 24-Pk NS FDA UDI
Identifiers
- Catalog Number
- 8603A FDA UDI
- Primary DI / UDI-DI
- 00810019801549 FDA UDI
- 510(k) Number
- K041541 FDA UDI
- FDA Product Code
- FYA FDA UDI
- GMDN Term
- Surgical gown, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical gown, reusable
SRI Healthcare by SRI Healthcare, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K041541 also covers:
- SRI Healthcare — SRI Healthcare, LLC
- ComPel MLR Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel MLR Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel MLR Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel MLR Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel MLR Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel MLR Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel MLR Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel MLR Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel MLR Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel MLR Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel MLR Surgical Gown — 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 |
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Manufacturer
- Manufacturer
- SRI Healthcare, LLC
Sources (1)
- FDA UDI 6efd7908-5027-429d-8be8-f2a81552e64a 36 fields · synced Jun 8, 2026