Rochester - Rochester: SPECIALTYCARE DISPOSABLE SUBDERMAL - ROCHESTER ELECTRO-MEDICAL, INC.

Duns Number:068156330

Device Description: Rochester: SPECIALTYCARE DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.5 Rochester: SPECIALTYCARE DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 1.5 M TWISTED LEADWIRE, COLOR GROUP 3

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More Product Details

Catalog Number

-

Brand Name

Rochester

Version/Model Number

S82015-PT3-20SC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 20, 2019

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

-

Product Code Details

Product Code

GXZ

Product Code Name

Electrode, Needle

Device Record Status

Public Device Record Key

626e1ccf-792b-4c70-b9b5-f0ebf06afa14

Public Version Date

May 21, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10816843023352

Quantity per Package

20

Contains DI Package

10816843023369

Package Discontinue Date

May 20, 2019

Package Status

Not in Commercial Distribution

Package Type

-

"ROCHESTER ELECTRO-MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 83