FDA UDI In Commercial Distribution 🇺🇸 United States

KONG-TL VBR E, Expandable Body, Standalone, XS, Ø 19 mm x 22 - 29 mm

DI: 07640164847412 · Model: 12-91-1922-9 · icotec AG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
KONG-TL VBR E, Expandable Body, Standalone, XS, Ø 19 mm x 22 - 29 mm
Primary DI
07640164847412
Version / Model
12-91-1922-9
Catalog Number
12-91-1922-9
Company Name
icotec AG
Labeler DUNS
480789465
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-06-19
Public Version
1
Public Version Date
2020-06-29
Public Version Status
New
Public Device Record Key
a46ffbc3-f99d-4aee-bad7-c2af911e472c

Device Description

KONG-TL VBR E, Expandable Body, Standalone, XS, Ø 19 mm x 22 - 29 mm

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 Unsafe
Direct Marking Exempt
Yes
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
MQP Spinal Vertebral Body Replacement Device
PLR Spinal Vertebral Body Replacement Device - Cervical

GMDN Terms

Code Name
34170 Vertebral body prosthesis

Identifiers

Type ID
Primary 07640164847412

Customer Contacts

Phone
+41717570000