Innomed, Inc. - Impact Mallet 2lbs Delrin Cap EZ Grip Handle - INNOMED, INC.

Duns Number:878427491

Device Description: Impact Mallet 2lbs Delrin Cap EZ Grip Handle

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More Product Details

Catalog Number

7832

Brand Name

Innomed, Inc.

Version/Model Number

7832

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)

-

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

FZY

Product Code Name

Hammer, Surgical

Device Record Status

Public Device Record Key

fba7f151-78a5-41c1-9953-40149e987592

Public Version Date

February 18, 2020

Public Version Number

1

DI Record Publish Date

February 10, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INNOMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2683
2 A medical device with a moderate to high risk that requires special controls. 14