MEDLINE - NEEDLE ELECTRODE 6' - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: NEEDLE ELECTRODE 6'

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More Product Details

Catalog Number

ESE15526

Brand Name

MEDLINE

Version/Model Number

ESE15526

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"

Yes

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

-

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Device Record Status

Public Device Record Key

9fca9d17-dae7-4ec0-9980-aa0af55df7f9

Public Version Date

May 26, 2020

Public Version Number

1

DI Record Publish Date

May 18, 2020

Additional Identifiers

Package DI Number

40080196916208

Quantity per Package

50

Contains DI Package

10080196916207

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"MEDLINE INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38540
2 A medical device with a moderate to high risk that requires special controls. 85094
3 A medical device with high risk that requires premarket approval 2
U Unclassified 7