← Back to catalogue

Hexanium® TLIF

FDA UDI

Class I (US FDA UDI)

by Spine Vision, Inc.

Identity

Trade Name
Hexanium® TLIF FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Straight Rake Curette FDA UDI
Model / Reference
TL3-A033 FDA UDI
Description
Straight Rake Curette FDA UDI

Identifiers

Primary DI / UDI-DI
03663136031835 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, 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

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

Hexanium® TLIF by Spine Vision, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Spine Vision, Inc.

Sources (1)

  • FDA UDI 462f69d9-0eb6-4490-a21b-0ad203d253ec 34 fields · synced Jun 6, 2026