POTENZA Tip - POTENZA Tip (Sterile micro needle electrode S-25 - Jeisys Medical Inc.

Duns Number:690275362

Device Description: POTENZA Tip (Sterile micro needle electrode S-25 Tip)

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More Product Details

Catalog Number

-

Brand Name

POTENZA Tip

Version/Model Number

S-25

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

K192545

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

e3706100-8ff6-4fa2-8b55-9b0c8dbca829

Public Version Date

March 06, 2020

Public Version Number

1

DI Record Publish Date

February 27, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JEISYS MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 36