FDA UDI In Commercial Distribution 🇺🇸 United States

CONDUIT ATP Cobb 22mm 36° Right

DI: 09421028118514 · Model: 287361364 · ENZTEC LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CONDUIT ATP Cobb 22mm 36° Right
Primary DI
09421028118514
Version / Model
287361364
Catalog Number
287361364
Company Name
ENZTEC LIMITED
Labeler DUNS
592616445
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-12-04
Public Version
1
Public Version Date
2023-12-12
Public Version Status
New
Public Device Record Key
94a24ba6-a2d4-46b2-9301-5eeeb8173985

Device Description

Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.

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
No
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
MAX Intervertebral Fusion Device With Bone Graft, Lumbar

GMDN Terms

Code Name
12696 Orthopaedic implant inserter/extractor, reusable

Identifiers

Type ID
Primary 09421028118514