Model: AR-3610DCS
Catalog: AR-3610DCS
DI: 00888867520783
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Description
KL FT Curve Guide, Disp Kit Short
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
62432cfc-487b-4026-9bb1-ad2582154c04
Distribution Status:
In Commercial Distribution
DUNS Number:
131747628
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00888867520783
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44052
Name: Orthopaedic surgical procedure kit, non-medicated, single-use
Definition:
A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.
FDA Product Codes
LXH
Orthopedic manual surgical instrument