NA - ELECTRODE DSE1125 48PK 15X20MM 2.5M ROHS - MEDTRONIC XOMED, INC.

Duns Number:835465063

Device Description: ELECTRODE DSE1125 48PK 15X20MM 2.5M ROHS

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

DSE1125

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

K850108,K850108

Product Code Details

Product Code

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Device Record Status

Public Device Record Key

c125355d-9454-4c3c-8c58-0ac81f93ea5d

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