MYO/WIRE™ Disposable Patient Cable 2.0 - Disposable Patient Cable, 1 per pouch - A & E MEDICAL CORPORATION

Duns Number:173770868

Device Description: Disposable Patient Cable, 1 per pouch

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More Product Details

Catalog Number

-

Brand Name

MYO/WIRE™ Disposable Patient Cable 2.0

Version/Model Number

019-530

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

13792a15-b970-4f80-9559-ab24d6697aea

Public Version Date

November 22, 2018

Public Version Number

5

DI Record Publish Date

November 29, 2016

Additional Identifiers

Package DI Number

20841291105265

Quantity per Package

8

Contains DI Package

10841291105268

Package Discontinue Date

-

Package Status

In Commercial Distribution

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