Identity
- Trade Name
- ST.A.R. 90 F4 FDA UDI
- Generic Name
- Surgical instrument torque limiter FDA UDI
- Model / Reference
- Torque wrench FDA UDI
Identifiers
- Catalog Number
- F4-0205 FDA UDI
- Primary DI / UDI-DI
- 08032909629923 FDA UDI
- 510(k) Number
- K113384 FDA UDI
- FDA Product Code
- JDW FDA UDIKTT FDA UDI
- GMDN Term
- Surgical instrument torque limiter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument torque limiter
St.a.r. 90 F4 by Citieffe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument torque limiter.
- Pisces-SA — OSSEUS FUSION SYSTEMS LLC · Class I
- MobileLink Acetabular Cup System - Instruments — WALDEMAR LINK GmbH & Co. KG · Class I
- Versalink Torque Limiter — PREMIA SPINE LTD · Class II
- VersaLink Torque Limiter — PREMIA SPINE LTD · Class II
- Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc. · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- CarboClear X Pedicle Screw System — CARBOFIX ORTHOPEDICS LTD · Class II
- MobileLink Acetabular Cup System - Instruments — WALDEMAR LINK GmbH & Co. KG · Class I
Cleared under the same submission
K113384 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Citieffe
Sources (1)
- FDA UDI b5e92930-dfac-436c-b5c0-b1e458e00c33 36 fields · synced Jun 1, 2026