Greenwald Surgical Company, Inc. - VanBuren Urethral Sound, Curved - GRACE MANUFACTURING, INC.

Duns Number:607903382

Device Description: VanBuren Urethral Sound, Curved

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

U343

Brand Name

Greenwald Surgical Company, Inc.

Version/Model Number

58110-36

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

-

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

FBX

Product Code Name

Sound, Urethral, Metal Or Plastic

Device Record Status

Public Device Record Key

0af4964e-8f07-4e99-b066-a8a2a947a650

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GRACE MANUFACTURING, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 186
2 A medical device with a moderate to high risk that requires special controls. 220