A&E Medical / Rotating Surgical Punches - Rotating Surgical Punches, 20 per Box - A & E MEDICAL CORPORATION

Duns Number:173770868

Device Description: Rotating Surgical Punches, 20 per Box

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More Product Details

Catalog Number

-

Brand Name

A&E Medical / Rotating Surgical Punches

Version/Model Number

080-502

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

Yes

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

LRY

Product Code Name

Punch, Surgical

Device Record Status

Public Device Record Key

931caaf1-64bb-4213-a868-3af43b71d4d7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"A & E MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 27
2 A medical device with a moderate to high risk that requires special controls. 621