CathGrip - CathGrip Double Strap with Wing Seal, No Alcohol, - BIODERM, INC.

Duns Number:114773653

Device Description: CathGrip Double Strap with Wing Seal, No Alcohol, Sterile

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More Product Details

Catalog Number

-

Brand Name

CathGrip

Version/Model Number

51303NA

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

Yes

Prescription Use (Rx)

-

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

KMK

Product Code Name

Device, Intravascular Catheter Securement

Device Record Status

Public Device Record Key

44e0dd74-bf6e-4787-b847-02fb983ee540

Public Version Date

February 04, 2021

Public Version Number

1

DI Record Publish Date

January 27, 2021

Additional Identifiers

Package DI Number

10653599001384

Quantity per Package

30

Contains DI Package

00653599001387

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"BIODERM, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 84