FDA UDI Not in Commercial Distribution 🇺🇸 United States

Ziehm Vision2

DI: EZIEZIEHMVISION1 · Model: 30355 · Ziehm Imaging GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Ziehm Vision2
Primary DI
EZIEZIEHMVISION1
Version / Model
30355
Company Name
Ziehm Imaging GmbH
Labeler DUNS
322720541
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
5
Public Version Date
2023-07-31
Public Version Status
Update
Public Device Record Key
159038b2-422a-4a16-b282-0bd8a010ad43
Distribution End Date
2020-09-30

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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JAK System, X-Ray, Tomography, Computed

GMDN Terms

Code Name
37646 Mobile general-purpose fluoroscopic x-ray system, digital

Identifiers

Type ID
Primary EZIEZIEHMVISION1

Premarket Submissions

Submission Number Supplement Number
K073346 000