Identity
- Trade Name
- Swift Urology Retractor Basic Set FDA UDI
- Generic Name
- Self-retaining surgical retractor, reusable FDA UDI
- Device Name
- Swift Urology Retractor Basic Radiolucent Set Consists of the Following:: 1 x 9881-10, 1 x 9881-12, 1 x 9881-24, 1 x 9881-26, 4 x 9881-70, 1 x 9881-90, 1 x 9881-92, 2 x 9882-10R, 2 x 9882-14R, 1 x 9882-30R, 1 x 9882-32R, 1 x 9882-40R, 1 x 9882-44R, 1 x 9882-60R, 1 x 9882-62R, 1 x 9882-72R, 1 x 9882-74R, 1 x 9883-12R, 1 x 9883-16R & 1 x 9883-50R FDA UDI
- Model / Reference
- 9880-20R FDA UDI
- Description
- Swift Urology Retractor Basic Radiolucent Set Consists of the Following:: 1 x 9881-10, 1 x 9881-12, 1 x 9881-24, 1 x 9881-26, 4 x 9881-70, 1 x 9881-90, 1 x 9881-92, 2 x 9882-10R, 2 x 9882-14R, 1 x 9882-30R, 1 x 9882-32R, 1 x 9882-40R, 1 x 9882-44R, 1 x 9882-60R, 1 x 9882-62R, 1 x 9882-72R, 1 x 9882-74R, 1 x 9883-12R, 1 x 9883-16R & 1 x 9883-50R FDA UDI
Identifiers
- Catalog Number
- 9880-20R FDA UDI
- Primary DI / UDI-DI
- 10840199544773 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
Swift Urology Retractor Basic Set 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 a2a55b2f-3332-4ee3-84ee-d78a79cc5c72 37 fields · synced Jun 1, 2026