Identity
- Trade Name
- CAPTURE Facet Screw Set System FDA UDI
- Generic Name
- Spinal guidewire FDA UDI
- Device Name
- Cannula cleaner FDA UDI
- Model / Reference
- 70-02-012 FDA UDI
- Description
- Cannula cleaner FDA UDI
Identifiers
- Catalog Number
- 430-0027 FDA UDI
- Primary DI / UDI-DI
- M7404300027 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Spinal guidewire 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
MR Unsafe FDA UDI
Category: Spinal guidewire
CAPTURE Facet Screw Set System by Spineology Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal guidewire.
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- Cortera — Xtant Medical Holdings, Inc. · Class I
- Cortera — Xtant Medical Holdings, Inc. · Class I
- RAVINE® Lateral Access System — K2M, INC. · Class I
- NILE™ Spinal System — K2M, INC. · Class II
- MEGA PLUS MIS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
- DeGen Standard Instrumentation — Degen Medical · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spineology Inc.
Sources (1)
- FDA UDI 0a55c6f6-3b34-4e2f-a2ee-e154b7d6cb15 35 fields · synced Jun 1, 2026