Universal Funnel Adapter - Universal Funnel Adapter-Luer Lock - URESIL, LLC

Duns Number:192559557

Device Description: Universal Funnel Adapter-Luer Lock

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More Product Details

Catalog Number

UFA-LL

Brand Name

Universal Funnel Adapter

Version/Model Number

UFA-LL

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)

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

GBO

Product Code Name

Catheter, Nephrostomy, General & Plastic Surgery

Device Record Status

Public Device Record Key

3ba82a1f-4984-41c2-b7db-d19501cfc710

Public Version Date

April 15, 2022

Public Version Number

2

DI Record Publish Date

March 24, 2022

Additional Identifiers

Package DI Number

20817640020817

Quantity per Package

50

Contains DI Package

00817640020813

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper

"URESIL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 179
2 A medical device with a moderate to high risk that requires special controls. 77
U Unclassified 24