Model: 51-GW-500-SHARP
Catalog: 51-GW-500-SHARP
DI: 00840311246786
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
Guidewire 1.5mm X 500mm, Sharp Tip - NIT
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ce5ee5b1-aed3-4512-9ed0-76f00a0d2557
Distribution Status:
In Commercial Distribution
DUNS Number:
081224143
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00846468052171
Item #1 - Device ID Type:
Previous
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00840311246786
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 63819
Name: Spinal guidewire
Definition:
A thin, non-implantable rod intended to guide the insertion of a cannulated orthopaedic implant (typically a screw) and/or surgical instrument (e.g., cannula, drill bit) during spinal surgery. This is a single-use device.
FDA Product Codes
MNH
Orthosis, spondylolisthesis spinal fixation
MNI
Orthosis, spinal pedicle fixation
Premarket Submissions
Submission Number:
K130286
Supplement Number:
000