FDA UDI Not in Commercial Distribution 🇺🇸 United States

LF

DI: 10746190002451 · Model: 700540 · Liebel-Flarsheim Company LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
LF
Primary DI
10746190002451
Version / Model
700540
Company Name
Liebel-Flarsheim Company LLC
Labeler DUNS
080186051
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-09
Public Version
6
Public Version Date
2022-01-05
Public Version Status
Update
Public Device Record Key
87dc2f52-0610-4776-82d6-4a57a78aad8f
Distribution End Date
2019-10-11

Device Description

Hydra Vision Urology System, 80 kW

Device Characteristics

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IXR Table, Radiographic, Tilting

GMDN Terms

Code Name
37633 Stationary uro-gynaecological fluoroscopic x-ray system, digital

Identifiers

Type ID
Primary 10746190002451

Premarket Submissions

Submission Number Supplement Number
K943581 000