Identity
- Trade Name
- EZ Access™ FDA UDI
- Generic Name
- Radial surgical retractor FDA UDI
- Device Name
- Wound Protector/ Retractor FDA UDI
- Model / Reference
- 1425-S FDA UDI
- Description
- Wound Protector/ Retractor FDA UDI
Identifiers
- Primary DI / UDI-DI
- B5911425S0 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
EZ Access™ by Vlv Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- CleanCision Wound Retraction and Protection System — Prescient Surgical, Inc. · Class II
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- Alexis ® O C-Section Protector - Retractor — APPLIED MEDICAL RESOURCES CORP. · Class II
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
- Vlv Associates, Inc.
Sources (1)
- FDA UDI f3f5e381-374b-44ae-a613-e2c0f61ad787 34 fields · synced Jun 6, 2026