FDA UDI In Commercial Distribution 🇺🇸 United States

GIZA

DI: 07640167930449 · Model: Giza Implant sizing gauge · Eden Spine Europe SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
GIZA
Primary DI
07640167930449
Version / Model
Giza Implant sizing gauge
Catalog Number
1009X
Company Name
Eden Spine Europe SA
Labeler DUNS
482797425
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-09-24
Public Version
1
Public Version Date
2018-10-25
Public Version Status
New
Public Device Record Key
32d9840f-7fb3-465b-93a3-9743aa5afd61

Device Description

Orthopaedic manual surgical instrument.

Device Characteristics

Single Use
Yes
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LXH Orthopedic Manual Surgical Instrument

GMDN Terms

Code Name
35788 Orthopaedic bone calliper

Identifiers

Type ID
Primary 07640167930449