MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE - 0.018" (0.47MM) X 45CM NITINOL GUIDEWIRE - JET MEDICAL, INC.

Duns Number:079506014

Device Description: 0.018" (0.47MM) X 45CM NITINOL GUIDEWIRE

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More Product Details

Catalog Number

-

Brand Name

MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE

Version/Model Number

JT140184500

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

DQX

Product Code Name

Wire, Guide, Catheter

Device Record Status

Public Device Record Key

2948d507-c673-4ea8-910d-8e599fe5511d

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

April 13, 2018

Additional Identifiers

Package DI Number

50810988021264

Quantity per Package

10

Contains DI Package

00810988021269

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"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