Grip-Lok - Small Foley Catheter Securement Device, For 2 & 3 - TIDI PRODUCTS, LLC

Duns Number:063519193

Device Description: Small Foley Catheter Securement Device, For 2 & 3 Way Foley Catheters Sized 8-30 Fr

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More Product Details

Catalog Number

3600PFC

Brand Name

Grip-Lok

Version/Model Number

3600PFC

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

EYJ

Product Code Name

Holder, Ureteral Catheter

Device Record Status

Public Device Record Key

abb7f78d-d6b9-4297-a655-a8e7f19eaac2

Public Version Date

October 21, 2022

Public Version Number

1

DI Record Publish Date

October 13, 2022

Additional Identifiers

Package DI Number

10618125134899

Quantity per Package

100

Contains DI Package

00618125134892

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"TIDI PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 222
2 A medical device with a moderate to high risk that requires special controls. 2255