← Back to catalogue

NILE™ Spinal System

FDA UDI

Class II (US FDA UDI)

by K2m, Inc.

Identity

Trade Name
NILE™ Spinal System FDA UDI
Generic Name
Spinal guidewire FDA UDI
Device Name
Wire Pack, Qty 4 FDA UDI
Model / Reference
3711-G13610 FDA UDI
Description
Wire Pack, Qty 4 FDA UDI

Identifiers

Catalog Number
3711-G13610 FDA UDI
Primary DI / UDI-DI
10888857083844 FDA UDI
FDA Product Code
JDQ FDA UDI
GMDN Term
Spinal guidewire FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3010 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

No

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

NILE™ Spinal System by K2m, Inc. — Class II — 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

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

Manufacturer

Manufacturer
K2m, Inc.

Sources (1)

  • FDA UDI 4743da3e-5f41-4994-880e-48c5e0fdc5f6 35 fields · synced May 29, 2026