Model: 101.000
DI: 00840277412034
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
Titanium Button
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0e30f158-e288-44b1-91b2-5eef955f135d
Distribution Status:
In Commercial Distribution
DUNS Number:
964053560
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:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00840277412034
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 45062
Name: Tendon/ligament bone anchor, non-bioabsorbable
Definition:
A non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].
FDA Product Codes
MBI
Fastener, Fixation, Nondegradable, Soft Tissue