DLW,3LD,PINCH,MULTI LINK,40",INTERMED - DLW,3LD,PINCH,MULTI LINK,40",INTERMED - CURBELL MEDICAL PRODUCTS, INC.

Duns Number:796452311

Device Description: DLW,3LD,PINCH,MULTI LINK,40",INTERMED

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More Product Details

Catalog Number

18932

Brand Name

DLW,3LD,PINCH,MULTI LINK,40",INTERMED

Version/Model Number

DLW-03BD-40AM-3000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 28, 2017

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

Product Code Details

Product Code

DSA

Product Code Name

Cable, Transducer And Electrode, Patient, (Including Connector)

Device Record Status

Public Device Record Key

b0394ff5-f5af-4c33-a7b8-b27de063616f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

90840828101304

Quantity per Package

2

Contains DI Package

90840828100888

Package Discontinue Date

December 28, 2017

Package Status

Not in Commercial Distribution

Package Type

-

"CURBELL MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 478
2 A medical device with a moderate to high risk that requires special controls. 8062