FDA UDI In Commercial Distribution 🇺🇸 United States

Vertefix

DI: 06009696221847 · Model: MI5100T · ELITE SURGICAL SUPPLIES (PTY) LTD
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Vertefix
Primary DI
06009696221847
Version / Model
MI5100T
Catalog Number
MI5100T
Company Name
ELITE SURGICAL SUPPLIES (PTY) LTD
Labeler DUNS
568359710
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
4
Public Version Date
2019-01-17
Public Version Status
Update
Public Device Record Key
dfd12827-8463-4882-a127-861bef591846

Device Description

Alignment Rod Titanium 5.0x100mm

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
Yes
Not Made with NRL
No
MRI Safety
MR Conditional
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
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
KWP Appliance, Fixation, Spinal Interlaminal
MNH Orthosis, Spondylolisthesis Spinal Fixation
MNI Orthosis, Spinal Pedicle Fixation

GMDN Terms

Code Name
37272 Trans-facet-screw internal spinal fixation system, sterile

Identifiers

Type ID
Primary 06009696221847