Identity
- Trade Name
- V. Mueller FDA UDI
- Generic Name
- Surgical retraction system, reusable FDA UDI
- Device Name
- SHADOW-LINE DISTRACTION KIT DN WITH DINCD3-5B FDA UDI
- Model / Reference
- Z-0102DD FDA UDI
- Description
- SHADOW-LINE DISTRACTION KIT DN WITH DINCD3-5B FDA UDI
Identifiers
- Catalog Number
- Z0102DD FDA UDI
- Primary DI / UDI-DI
- 10885403175886 FDA UDI
- 510(k) Number
- K964402 FDA UDI
- FDA Product Code
- GZT FDA UDI
- GMDN Term
- Surgical retraction system, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4800 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
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical retraction system, reusable
V. Mueller by Steris Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retraction system, reusable.
- 45930R — Thompson Surgical Instruments, Inc. · Class IIa
- Sigma — ALPHATEC SPINE, INC. · Class I
- Omni-Tract® — Integra Lifesciences Corp. · Class I
- Drills and Handpieces — SOUTHERN IMPLANTS (PTY) LTD · Class IIa
- Thompson — Thompson Surgical Instruments · Class I
- Nordent Manufacturing, Inc. — NORDENT MANUFACTURING INC · Class I
- Thompson — Thompson Surgical Instruments · Class I
- Thompson — Thompson Surgical Instruments · Class I
Cleared under the same submission
K964402 also covers:
- V. Mueller — STERIS CORPORATION
- V. Mueller — STERIS CORPORATION
- V. Mueller — STERIS CORPORATION
- V. Mueller — STERIS CORPORATION
- V. Mueller — STERIS CORPORATION
- V. Mueller — STERIS CORPORATION
- V. Mueller — STERIS CORPORATION
- V. Mueller — STERIS CORPORATION
- V. Mueller — STERIS CORPORATION
- V. Mueller — STERIS CORPORATION
- V. Mueller — STERIS CORPORATION
- V. Mueller — STERIS CORPORATION
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
- Steris Corporation
Sources (1)
- FDA UDI afff2deb-17bc-4488-a6ce-de1ddf6dc99d 36 fields · synced Jun 8, 2026