Identity
- Trade Name
- Vista Improved Extended Retractor System FDA UDI
- Generic Name
- Self-retaining surgical retractor, reusable FDA UDI
- Device Name
- Vista Improved Extended Retractor System Consists of the Following: 1 x 7319-11, 1 x 7319-12, 1 x 7319-13, 2 x 7319-20, 1 x 7319-21, 2 x 7319-30, 2 x 7319-31, 2 x 7319-32, 2 x 7319-33, 2 x 7319-34, 2 x 7319-35, 2 x 7319-36, 2 x 7319-37, 2 x 7319-38, 2 x 7319-39, 1 x 7319-40, 1 x 7319-41, 1 x 7319-42, 1 x 7319-43, 1 x 7319-44, 1 x 7319-45, 1 x 7319-46, 1 x 7319-47, 1 x 7319-48, 1 x 7319-50, 1 x 7319-51, 1 x 7319-52, 1 x 7319-53, 1 x 7319-54, 1 x 7319-55, 1 x 7319-56, 1 x 7319-57, 2 x 7319-60, 2 x 7319-61, 2 x 7319-62, 2 x 7319-63, 2 x 7319-64, 2 x 7319-65, 2 x 7319-66, 2 x 7319-67, 2 x 7319-70, 2 x 7319-71, 2 x 7319-72, 2 x 7319-73, 2 x 7319-74, 2 x 7319-75, 2 x 7319-76 & 2 x 7319-77 FDA UDI
- Model / Reference
- 7319-02 FDA UDI
- Description
- Vista Improved Extended Retractor System Consists of the Following: 1 x 7319-11, 1 x 7319-12, 1 x 7319-13, 2 x 7319-20, 1 x 7319-21, 2 x 7319-30, 2 x 7319-31, 2 x 7319-32, 2 x 7319-33, 2 x 7319-34, 2 x 7319-35, 2 x 7319-36, 2 x 7319-37, 2 x 7319-38, 2 x 7319-39, 1 x 7319-40, 1 x 7319-41, 1 x 7319-42, 1 x 7319-43, 1 x 7319-44, 1 x 7319-45, 1 x 7319-46, 1 x 7319-47, 1 x 7319-48, 1 x 7319-50, 1 x 7319-51, 1 x 7319-52, 1 x 7319-53, 1 x 7319-54, 1 x 7319-55, 1 x 7319-56, 1 x 7319-57, 2 x 7319-60, 2 x 7319-61, 2 x 7319-62, 2 x 7319-63, 2 x 7319-64, 2 x 7319-65, 2 x 7319-66, 2 x 7319-67, 2 x 7319-70, 2 x 7319-71, 2 x 7319-72, 2 x 7319-73, 2 x 7319-74, 2 x 7319-75, 2 x 7319-76 & 2 x 7319-77 FDA UDI
Identifiers
- Catalog Number
- 7319-02 FDA UDI
- Primary DI / UDI-DI
- 10840199543578 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Self-retaining surgical retractor, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Self-retaining surgical retractor, reusable
Vista Improved Extended Retractor System by Koros USA, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Koros USA, Inc.
Sources (1)
- FDA UDI d171f7f1-33fa-4dc3-9971-ac1808229f96 37 fields · synced Jun 1, 2026