N/A - ELECTRODE 8228053 APS 3MM ROHS - MEDTRONIC XOMED, INC.

Duns Number:835465063

Device Description: ELECTRODE 8228053 APS 3MM ROHS

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

8228053

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

K083124

Product Code Details

Product Code

ETN

Product Code Name

STIMULATOR, NERVE

Device Record Status

Public Device Record Key

9ee077ea-5b3c-4c0b-acc3-ac5578413547

Public Version Date

June 18, 2019

Public Version Number

1

DI Record Publish Date

June 10, 2019

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