FDA UDI In Commercial Distribution 🇺🇸 United States

EZ-TRAX™

DI: 00850006159475 · Model: 00850006159475 · K1 MEDICAL TECHNOLOGIES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
EZ-TRAX™
Primary DI
00850006159475
Version / Model
00850006159475
Catalog Number
BRACKETASSY-S-2.4-STDRD-0.50
Company Name
K1 MEDICAL TECHNOLOGIES, LLC
Labeler DUNS
080448429
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-01-25
Public Version
6
Public Version Date
2022-09-16
Public Version Status
Update
Public Device Record Key
477ff0e3-c53d-4e5a-8a7b-f787e86641fa

Device Description

Bracket Silicone (H) 2.4 Standard Round Dia. .500

Device Characteristics

Single Use
No
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
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
FSM Tray, Surgical, Instrument

GMDN Terms

Code Name
12143 Instrument tray, reusable

Identifiers

Type ID
Primary 00850006159475