Greenwald Surgical Company, Inc. - SPECIAL GELMAN URETHROPLASTY GUIDE - GRACE MANUFACTURING, INC.

Duns Number:607903382

Device Description: SPECIAL GELMAN URETHROPLASTY GUIDE

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More Product Details

Catalog Number

-

Brand Name

Greenwald Surgical Company, Inc.

Version/Model Number

C9814-00

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

FFL

Product Code Name

Dislodger, Stone, Basket, Ureteral, Metal

Device Record Status

Public Device Record Key

d1dfd7ee-8e41-415b-bf7b-debb4ecc50f6

Public Version Date

March 21, 2019

Public Version Number

3

DI Record Publish Date

December 12, 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