Ultima - Ultima Cable for HRCA Manometry Probe (Lemo - DIVERSATEK HEALTHCARE, INC.

Duns Number:030650113

Device Description: Ultima Cable for HRCA Manometry Probe (Lemo Connector)

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


More Product Details

Catalog Number

H12R-7210

Brand Name

Ultima

Version/Model Number

H12R-7210

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

FFX

Product Code Name

System, Gastrointestinal Motility (Electrical)

Device Record Status

Public Device Record Key

245686cb-fcb5-4d8f-b03f-3951ab80d045

Public Version Date

March 09, 2021

Public Version Number

1

DI Record Publish Date

March 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIVERSATEK HEALTHCARE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 109
2 A medical device with a moderate to high risk that requires special controls. 207