Coleman Luer Lock Cap - Coleman Luer Lock Cap - MENTOR TEXAS L.P.

Duns Number:167450993

Device Description: Coleman Luer Lock Cap

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More Product Details

Catalog Number

COL-LLCAP

Brand Name

Coleman Luer Lock Cap

Version/Model Number

COL-LLCAP

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"

-

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

K981172,K981172,K981172

Product Code Details

Product Code

MUU

Product Code Name

System, suction, lipoplasty

Device Record Status

Public Device Record Key

99ce393b-b73f-4ad7-afab-f005d962117c

Public Version Date

November 09, 2021

Public Version Number

4

DI Record Publish Date

September 14, 2016

Additional Identifiers

Package DI Number

10081317023484

Quantity per Package

25

Contains DI Package

00081317023487

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

25 Pouches/Box

"MENTOR TEXAS L.P." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 17
2 A medical device with a moderate to high risk that requires special controls. 128
3 A medical device with high risk that requires premarket approval 545
U Unclassified 514