PROBE - KLS-Martin L.P.

Duns Number:826499238

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


More Product Details

Catalog Number

-

Brand Name

PROBE

Version/Model Number

35-220-77-07

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 20, 2021

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

HNL

Product Code Name

Probe, lachrymal

Device Record Status

Public Device Record Key

daed614f-26b1-4097-8bfc-1790bb4d1908

Public Version Date

April 21, 2021

Public Version Number

5

DI Record Publish Date

December 21, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KLS-MARTIN L.P." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7013
2 A medical device with a moderate to high risk that requires special controls. 4618