Worker™ Guidewire - Worker™ Guidewire - Amplatz Straight .035" x - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: Worker™ Guidewire - Amplatz Straight .035" x 90cm, 7.5cm Tip

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More Product Details

Catalog Number

124035090

Brand Name

Worker™ Guidewire

Version/Model Number

124035090

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

K160785,K160785

Product Code Details

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Device Record Status

Public Device Record Key

8362e729-a43b-4ae5-b3a1-534683833863

Public Version Date

September 24, 2018

Public Version Number

1

DI Record Publish Date

August 24, 2018

Additional Identifiers

Package DI Number

20886333224481

Quantity per Package

10

Contains DI Package

00886333224487

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ARGON MEDICAL DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 347
2 A medical device with a moderate to high risk that requires special controls. 1205