FDA UDI In Commercial Distribution 🇺🇸 United States

EXPERT - Flexible Joint Fixation System

DI: 07899258663869 · Model: EXPERT FAST DUAL - Dual Flexible Knotless Fixator for Syndesmosis with Inserter · GM DOS REIS INDUSTRIA E COMERCIO LTDA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
EXPERT - Flexible Joint Fixation System
Primary DI
07899258663869
Version / Model
EXPERT FAST DUAL - Dual Flexible Knotless Fixator for Syndesmosis with Inserter
Catalog Number
314-2020
Company Name
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Labeler DUNS
900865213
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-11-05
Public Version
2
Public Version Date
2025-12-08
Public Version Status
Update
Public Device Record Key
eef16035-482e-4aef-9866-8d7663fda43b

Device Description

EXPERT FAST DUAL - Dual Flexible Knotless Fixator for Syndesmosis with Inserter

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Conditional
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
HTN Washer, Bolt Nut

GMDN Terms

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

Identifiers

Type ID
Primary 07899258663869