5F X 8.5CM ALLEVIO SPG NERVE BLOCK CATHETER SET - 5F X 8.5CM ALLEVIO SPG NERVE BLOCK CATHETER SET - JET MEDICAL, INC.

Duns Number:079506014

Device Description: 5F X 8.5CM ALLEVIO SPG NERVE BLOCK CATHETER SET

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More Product Details

Catalog Number

JT110500851

Brand Name

5F X 8.5CM ALLEVIO SPG NERVE BLOCK CATHETER SET

Version/Model Number

JT110500851

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 22, 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"

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

KCJ

Product Code Name

Applicator, Ent

Device Record Status

Public Device Record Key

f9fc0205-aea7-407a-b761-ed2aca5316ba

Public Version Date

May 03, 2019

Public Version Number

4

DI Record Publish Date

August 25, 2015

Additional Identifiers

Package DI Number

50810988020540

Quantity per Package

5

Contains DI Package

00810988020545

Package Discontinue Date

April 22, 2019

Package Status

Not in Commercial Distribution

Package Type

-

"JET MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 63