Identity
- Trade Name
- Xia 3 FDA UDI
- Generic Name
- Torque manipulation device FDA UDI
- Device Name
- Specialty Xia 3 Two Pronged Anti-Torque Key FDA UDI
- Model / Reference
- IS4498XLP FDA UDI
- Description
- Specialty Xia 3 Two Pronged Anti-Torque Key FDA UDI
Identifiers
- Catalog Number
- IS4498XLP FDA UDI
- Primary DI / UDI-DI
- 07613327480115 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Torque manipulation device 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Torque manipulation device
Xia 3 by Stryker Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Torque manipulation device.
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- K2M General Instruments — K2M, INC. · Class I
- Cook — COOK INCORPORATED · Class I
- Torque Device for Guidewire — Amsinomed Medical Co., Ltd · 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
- Stryker Corp.
Sources (1)
- FDA UDI e062fda6-9a11-41e7-803b-cd790b6d6f04 34 fields · synced May 30, 2026