Identity
- Trade Name
- ComPel XTR OR Gown FDA UDI
- Generic Name
- Surgical gown, reusable FDA UDI
- Device Name
- OR GWN COMPL XTR KAUM L/XL BLU - RM (98 6749) USE: 75667265 FDA UDI
- Model / Reference
- 756672K5 FDA UDI
- Description
- OR GWN COMPL XTR KAUM L/XL BLU - RM (98 6749) USE: 75667265 FDA UDI
Identifiers
- Catalog Number
- 756672K5 FDA UDI
- Primary DI / UDI-DI
- 00634916024463 FDA UDI
- 510(k) Number
- K922753 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
- Not 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
ComPel XTR OR Gown by Standard Textile Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Standard Textile Co., Inc.
Sources (1)
- FDA UDI 0b91aca2-2f9f-409c-b97e-283b7463fa26 37 fields · synced May 30, 2026