Map-iT - Shrouded Quad Extension Cable, Red, Reusable - ACCESS POINT TECHNOLOGIES, INC.

Duns Number:128599565

Device Description: Shrouded Quad Extension Cable, Red, Reusable

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More Product Details

Catalog Number

901953

Brand Name

Map-iT

Version/Model Number

901953

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

IKD

Product Code Name

Cable, Electrode

Device Record Status

Public Device Record Key

2dbe918b-0c1f-4b6e-b7d5-ac9faab9f699

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 11, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACCESS POINT TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 428