Greenwald Surgical Company, Inc. - ACTIVE CORD W/BOVIE M.P. & DOWNS RECESSED TIP AND - GRACE MANUFACTURING, INC.

Duns Number:607903382

Device Description: ACTIVE CORD W/BOVIE M.P. & DOWNS RECESSED TIP AND BUSHING

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More Product Details

Catalog Number

C0109-01

Brand Name

Greenwald Surgical Company, Inc.

Version/Model Number

C0109-01

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

HGI

Product Code Name

Electrocautery, Gynecologic (And Accessories)

Device Record Status

Public Device Record Key

7349286e-af60-46d0-93b3-06beab06ff61

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 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