CathGrip - CathGrip Single Strap, Small, Non-Sterile, No - BIODERM, INC.

Duns Number:114773653

Device Description: CathGrip Single Strap, Small, Non-Sterile, No Alcohol

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More Product Details

Catalog Number

-

Brand Name

CathGrip

Version/Model Number

51250NSNA

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

a88d3e81-3a57-4ca9-8a8c-e9f97926f6b2

Public Version Date

January 16, 2020

Public Version Number

1

DI Record Publish Date

January 08, 2020

Additional Identifiers

Package DI Number

10653599000318

Quantity per Package

30

Contains DI Package

00653599000311

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