Identity
- Trade Name
- Ball Tip Guide Wire, Ø3x800mm, PPS FDA UDI
- Generic Name
- Orthopaedic guidewire, reusable FDA UDI
- Device Name
- Ball Tip Guide Wire, Ø3x800mm, PPS FDA UDI
- Model / Reference
- 1UI095A-S FDA UDI
- Description
- Ball Tip Guide Wire, Ø3x800mm, PPS FDA UDI
Identifiers
- Catalog Number
- 1UI095A-S FDA UDI
- Primary DI / UDI-DI
- 09120116973775 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
Ball Tip Guide Wire, Ø3x800mm, PPS by I.T.S. GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic guidewire, reusable.
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- 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 229cb78b-1ce5-47d9-833c-09fc77063043 35 fields · synced Jun 8, 2026