Guidewire - Guidewire - GALT MEDICAL CORP.

Duns Number:943156836

Device Description: Guidewire

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More Product Details

Catalog Number

SGW-056-61

Brand Name

Guidewire

Version/Model Number

SGW-056-61

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

K021990,K021990,K021990

Product Code Details

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Device Record Status

Public Device Record Key

0b23a879-5cd4-4a4e-b180-ec7dbad1ca61

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

July 03, 2017

Additional Identifiers

Package DI Number

20841268101504

Quantity per Package

25

Contains DI Package

10841268101507

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box

"GALT MEDICAL CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29
2 A medical device with a moderate to high risk that requires special controls. 696