FDA UDI Not in Commercial Distribution 🇺🇸 United States

Ziehm Imaging

DI: 00618125175352 · Model: 30877 · TIDI PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Ziehm Imaging
Primary DI
00618125175352
Version / Model
30877
Catalog Number
30877
Company Name
TIDI PRODUCTS, LLC
Labeler DUNS
063519193
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-09-29
Public Version
2
Public Version Date
2023-12-01
Public Version Status
Update
Public Device Record Key
4e23d585-38db-48c7-aa4d-7b84c2558008
Distribution End Date
2023-11-30

Device Description

Ziehm Imaging C-arm Equipment Covers Clear Polyethylene Sterile Fits Ziehm Vision 12 per Case

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
Yes
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
PUI Drape, Surgical, Exempt

GMDN Terms

Code Name
12535 Medical equipment drape, single-use

Identifiers

Type ID
Package 10618125175359
Primary 00618125175352
Previous 01618125175351