BIA Subject Cables - 6-Pin DIN Subject Cables (8 ft / 2.4 m Length) - R.J.L. SCIENCES, INC.

Duns Number:021842273

Device Description: 6-Pin DIN Subject Cables (8 ft / 2.4 m Length)

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More Product Details

Catalog Number

SC6PIN8

Brand Name

BIA Subject Cables

Version/Model Number

6-Pin Subject Cables (8 ft)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

Yes

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

af7c8c52-e208-4454-a28f-968060c50268

Public Version Date

May 25, 2018

Public Version Number

1

DI Record Publish Date

April 24, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"R.J.L. SCIENCES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14