Identity
- Trade Name
- Full Coverage Isolation Gown #RR-300FC FDA UDI
- Generic Name
- Surgical/examination garment kit FDA UDI
- Device Name
- Isolation Gown, SMS, AAMI Level 3, Full Coverage, Over the Head, Thumbloop with Elastic Wrist, Universal FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Isolation Gown, SMS, AAMI Level 3, Full Coverage, Over the Head, Thumbloop with Elastic Wrist, Universal FDA UDI
Identifiers
- Catalog Number
- RR300FC FDA UDI
- Primary DI / UDI-DI
- 00813360023042 FDA UDI
- FDA Product Code
- FYC FDA UDI
- GMDN Term
- Surgical/examination garment kit 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical/examination garment kit
Full Coverage Isolation Gown #RR-300FC by Icp Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Icp Medical, Llc
Sources (1)
- FDA UDI 796d0eed-c96f-48d6-999e-e8216e8fc6e8 34 fields · synced May 29, 2026