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RAVINE® Lateral Access System

FDA UDI

Class I (US FDA UDI)

by K2m, Inc.

Identity

Trade Name
RAVINE® Lateral Access System FDA UDI
Generic Name
Spinal guidewire FDA UDI
Device Name
Lateral Access Guide Wire, FDA UDI
Model / Reference
K2-27-2056-01 FDA UDI
Description
Lateral Access Guide Wire, FDA UDI

Identifiers

Catalog Number
K2-27-2056-01 FDA UDI
Primary DI / UDI-DI
10888857243910 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

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

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: Spinal guidewire

RAVINE® Lateral Access System by K2m, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal guidewire.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
K2m, Inc.

Sources (1)

  • FDA UDI 475407cb-1c01-40e7-8644-b4f3801253e0 35 fields · synced May 30, 2026