FDA UDI In Commercial Distribution 🇺🇸 United States

TeKForce

DI: 00810198920321 · Model: 2471A115 · TheraMicro, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TeKForce
Primary DI
00810198920321
Version / Model
2471A115
Company Name
TheraMicro, LLC
Labeler DUNS
133029114
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-04-17
Public Version
1
Public Version Date
2026-04-27
Public Version Status
New
Public Device Record Key
452e5191-5fef-4963-8eae-638b7e9cd8ea

Device Description

All-Suture Anchor 1.5 mm, with 1.3mm Tape and two 26mm 1/2 circle needles

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Safe
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
MBI Fastener, Fixation, Nondegradable, Soft Tissue

GMDN Terms

Code Name
45062 Tendon/ligament bone anchor, non-bioabsorbable

Identifiers

Type ID
Primary 00810198920321

Premarket Submissions

Submission Number Supplement Number
K223114 000