AccessGUDID - DEVICE: OPTY-LINE (00887517001283)

GUDID

Device Identifier (DI) Information

Brand Name: OPTY-LINE
Version or Model: KWS1-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KWS1-000
Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Primary DI Number: 00887517001283
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 837845234 *Terms of Use

Device Description: K-WIRE SLEEVE, 2MM

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35436	Manual wire driver	A hand-held manual surgical instrument (drill-like) designed to drive orthopaedic bone wires, e.g., Steinmann pins, Kirschner wires or K-Wires (thin needle-like pins of different thickness that are pointed for self-drilling) into fractured/deformed bones for their restoration. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: N/A

Device Record Status

Public Device Record Key: d3100857-2ca6-4eb2-b931-f0256260749c
Public Version Date: May 28, 2025
Public Version Number: 3
DI Record Publish Date: September 06, 2017