Hayden Medical - Hayden Mallet 7-1/2" (18.8cm), 9oz. (255 grams) - Hayden Medical, Inc.

Duns Number:618214410

Device Description: Hayden Mallet 7-1/2" (18.8cm), 9oz. (255 grams) stainless head, 1" (2.5cm) head with one s Hayden Mallet 7-1/2" (18.8cm), 9oz. (255 grams) stainless head, 1" (2.5cm) head with one stainless face & one replaceable nylon cap

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More Product Details

Catalog Number

190-794

Brand Name

Hayden Medical

Version/Model Number

190-794

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

HXL

Product Code Name

MALLET

Device Record Status

Public Device Record Key

64fc97e7-c421-47c3-b055-dac609ffbf02

Public Version Date

August 04, 2022

Public Version Number

1

DI Record Publish Date

July 27, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HAYDEN MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2893
2 A medical device with a moderate to high risk that requires special controls. 195