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Precision Drill-Wire, Ø3.2x390mm (2-Pack), PPS
FDA UDIClass I (US FDA UDI)
by I.T.S. GmbH
Identity
- Trade Name
- Precision Drill-Wire,Ø3.2x390mm (2-Pack), PPS FDA UDI
- Generic Name
- Orthopaedic guidewire, reusable FDA UDI
- Device Name
- Precision Drill-Wire,Ø3.2x390mm (2-Pack), PPS FDA UDI
- Model / Reference
- 1F0I017A-S FDA UDI
- Description
- Precision Drill-Wire,Ø3.2x390mm (2-Pack), PPS FDA UDI
Identifiers
- Catalog Number
- 1F0I017A-S FDA UDI
- Primary DI / UDI-DI
- 09120116978442 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic guidewire, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic guidewire, reusable
Precision Drill-Wire, Ø3.2x390mm (2-Pack), PPS by I.T.S. GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic guidewire, reusable.
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- ZERO-P — Synthes GmbH · Class IIa
- Guidewire, Nitinol, Double Blunt, 1.19 x 610mm — Captiva Spine · Class I
- Packing Block — Synthes GmbH · Class I
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
- I.T.S. GmbH
Sources (1)
- FDA UDI 422767d5-82c3-4bfd-9793-130701190715 35 fields · synced Jun 8, 2026