Custom Medical Specialties, Inc. - Double Infiltration Tumescent Pump Extension Set - CUSTOM ASSEMBLIES, INC.

Duns Number:948904735

Device Description: Double Infiltration Tumescent Pump Extension Set - Sterile

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More Product Details

Catalog Number

-

Brand Name

Custom Medical Specialties, Inc.

Version/Model Number

CMS-1219

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

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

ea891348-bd68-40e8-899e-d5a3dcacf45a

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

December 07, 2016

Additional Identifiers

Package DI Number

00815849021266

Quantity per Package

10

Contains DI Package

00815849021259

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CUSTOM ASSEMBLIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 78
2 A medical device with a moderate to high risk that requires special controls. 72