A&E Medical / Thorecon™ Double Cable Plate Kit (inc. screws & cable) - Double Cable Plate Kit (inc. screws & cable) - A & E MEDICAL CORPORATION

Duns Number:173770868

Device Description: Double Cable Plate Kit (inc. screws & cable)

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More Product Details

Catalog Number

-

Brand Name

A&E Medical / Thorecon™ Double Cable Plate Kit (inc. screws & cable)

Version/Model Number

94-1300-04

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

IKD

Product Code Name

Cable, Electrode

Device Record Status

Public Device Record Key

d6f0d281-b396-4407-86e2-b7a1adc6a33c

Public Version Date

December 24, 2018

Public Version Number

1

DI Record Publish Date

November 21, 2018

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