Model: AR-9953CB-T45
Catalog: AR-9953CB-T45
DI: 00888867504592
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Description
Cerclage Button, 4.5mm
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
49af6dc9-73f7-4b8f-b07d-07ae6afa0a61
Distribution Status:
In Commercial Distribution
DUNS Number:
131747628
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00888867504592
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 67083
Name: Orthopaedic fixation plate cerclage pin/eye
Definition:
A small implantable device designed to facilitate implantation of an orthopaedic fixation plate using cerclage cable or wire, whereby it attaches to the plate and/or underlying bone and provides a hole (eye) through which the cerclage cable is threaded. The pin portion may be one of a variety of designs which may be: 1) threaded into plate hole; 2) seated within a plate hole and inserted into the underlying bone; or 3) inserted into the drive hole of an appropriate screw head. It is used for plate fixation when screws are not an option. This is a single-use device.
FDA Product Codes
JDQ
Cerclage, fixation