Lead Adapter, For use with Multi-Lead Trial Cable to Guideline System - Lead Adapter, For use with Multi-Lead Trial Cable - FHC, INC.

Duns Number:108179458

Device Description: Lead Adapter, For use with Multi-Lead Trial Cable to Guideline System, 1X

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More Product Details

Catalog Number

MT-LA-01

Brand Name

Lead Adapter, For use with Multi-Lead Trial Cable to Guideline System

Version/Model Number

MT-LA-01-00610

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

-

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

K071364

Product Code Details

Product Code

GZL

Product Code Name

ELECTRODE, DEPTH

Device Record Status

Public Device Record Key

06cd2e77-5477-4e13-a584-838af71eb58a

Public Version Date

June 08, 2021

Public Version Number

4

DI Record Publish Date

July 01, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FHC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 476