N/A - NYLON/STAINLESS STEEL MALLET; 7 1/4''(18.5CM), - BLACK & BLACK SURGICAL, INC.

Duns Number:004382282

Device Description: NYLON/STAINLESS STEEL MALLET; 7 1/4''(18.5CM), 7OZ HEAD

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More Product Details

Catalog Number

B67202

Brand Name

N/A

Version/Model Number

B67202

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

889de8fa-eaa0-483c-8799-fdc51e112392

Public Version Date

September 29, 2022

Public Version Number

1

DI Record Publish Date

September 21, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BLACK & BLACK SURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5533
2 A medical device with a moderate to high risk that requires special controls. 240