Hayden Medical - Reynolds Transauxillary Breast Dissector 16" - Hayden Medical, Inc.

Duns Number:618214410

Device Description: Reynolds Transauxillary Breast Dissector 16" (40cm), fenestrated blade, rigid

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More Product Details

Catalog Number

405-720F

Brand Name

Hayden Medical

Version/Model Number

405-720F

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

GDI

Product Code Name

DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY

Device Record Status

Public Device Record Key

3ca9779c-c25f-44ca-b470-806008a7ff57

Public Version Date

August 24, 2022

Public Version Number

1

DI Record Publish Date

August 16, 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