N/A - 2 Tender Grip® Cannula fixation device - SALTER LABS

Duns Number:022721133

Device Description: 2 Tender Grip® Cannula fixation device

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More Product Details

Catalog Number

1005-0-25

Brand Name

N/A

Version/Model Number

1005-0

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"

Yes

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Device Record Status

Public Device Record Key

337db405-ed44-46d4-8bf6-b8f8547a50ee

Public Version Date

August 07, 2020

Public Version Number

5

DI Record Publish Date

November 30, 2016

Additional Identifiers

Package DI Number

10607411001021

Quantity per Package

25

Contains DI Package

00607411001024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SALTER LABS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 865
2 A medical device with a moderate to high risk that requires special controls. 1134