Custom Medical Specialties, Inc. - Polyvinyl Urological Drainage Bag for Siemens - CUSTOM ASSEMBLIES, INC.

Duns Number:948904735

Device Description: Polyvinyl Urological Drainage Bag for Siemens Systems - Non-Sterile

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More Product Details

Catalog Number

-

Brand Name

Custom Medical Specialties, Inc.

Version/Model Number

CMS-950P

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

BWN

Product Code Name

Table And Attachments, Operating-Room

Device Record Status

Public Device Record Key

093899ed-8af7-471d-9f33-6bc1478cedc4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 22, 2016

Additional Identifiers

Package DI Number

00815849020498

Quantity per Package

20

Contains DI Package

00815849020269

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