LF - Hydra Vision Digital Imaging System, Footstep - Liebel-Flarsheim Company LLC

Duns Number:080186051

Device Description: Hydra Vision Digital Imaging System, Footstep Assembly (Accessory)

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

LF

Version/Model Number

333138

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KQS

Product Code Name

Table, Cystometric, Non-Electric And Accessories

Device Record Status

Public Device Record Key

4e00ddf6-c64d-4b46-bf91-2ac78bd4ff65

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

December 31, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIEBEL-FLARSHEIM COMPANY LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 75