Identity
- Trade Name
- Alexis Wound Protector-Retractor FDA UDI
- Generic Name
- Radial surgical retractor FDA UDI
- Device Name
- Wound Retractor and Protector FDA UDI
- Model / Reference
- C8323 FDA UDI
- Description
- Wound Retractor and Protector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00607915132941 FDA UDI
- FDA Product Code
- KGW FDA UDI
- GMDN Term
- Radial surgical retractor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radial surgical retractor
Alexis Wound Protector-Retractor by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- EZ Access™ — VLV ASSOCIATES, INC. · Class II
- CleanCision™ Wound Retraction and Protection System — Prescient Surgical, Inc. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class I
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
- Applied Medical Resources Corp.
Sources (1)
- FDA UDI cb85f75d-6fbd-4ac6-bc6e-a5d32eb0d4cf 35 fields · synced May 31, 2026