SPATULA - KLS-Martin L.P.

Duns Number:826499238

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More Product Details

Catalog Number

-

Brand Name

SPATULA

Version/Model Number

96-241-59-01

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

HAO

Product Code Name

INSTRUMENT, SURGICAL, NON-POWERED

Device Record Status

Public Device Record Key

70c40687-992a-47e9-a35b-bd542daf4d6b

Public Version Date

April 21, 2021

Public Version Number

4

DI Record Publish Date

September 26, 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