NA - ELECTRODE DME1001 24PK 1.2M CORKSCR ROHS - MEDTRONIC XOMED, INC.

Duns Number:835465063

Device Description: ELECTRODE DME1001 24PK 1.2M CORKSCR ROHS

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

DME1001

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K061639,K061639

Product Code Details

Product Code

GWE

Product Code Name

STIMULATOR, PHOTIC, EVOKED RESPONSE

Device Record Status

Public Device Record Key

79f5ff06-9696-4394-9755-e88564152c78

Public Version Date

February 24, 2021

Public Version Number

4

DI Record Publish Date

April 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC XOMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 665
2 A medical device with a moderate to high risk that requires special controls. 1575
3 A medical device with high risk that requires premarket approval 6
U Unclassified 10