FDA UDI In Commercial Distribution 🇺🇸 United States

VENTANA P/T

DI: 00840606165754 · Model: 41022-514 · SPINAL ELEMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
VENTANA P/T
Primary DI
00840606165754
Version / Model
41022-514
Company Name
SPINAL ELEMENTS, INC.
Labeler DUNS
610712213
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-04-09
Public Version
2
Public Version Date
2022-10-26
Public Version Status
Update
Public Device Record Key
40e95d23-d527-43a7-b73e-612538dbbea5

Device Description

10MM X 22MM X 14MM 5° VENTANA™ P/T LUMBAR INTERBODY

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
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
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
MAX Intervertebral Fusion Device With Bone Graft, Lumbar

GMDN Terms

Code Name
38161 Metallic spinal interbody fusion cage

Identifiers

Type ID
Primary 00840606165754