SPARTACORE - HI-TORQUE SPARTACORE 14 Peripheral Guide Wire - ABBOTT VASCULAR INC.

Duns Number:964569052

Device Description: HI-TORQUE SPARTACORE 14 Peripheral Guide Wire .014 5.0 cm x 190 cm

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More Product Details

Catalog Number

1005202

Brand Name

SPARTACORE

Version/Model Number

1005202

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

-

Product Code Details

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Device Record Status

Public Device Record Key

46a7f9d1-70fa-4f20-bfa1-26ddb2a33d77

Public Version Date

March 23, 2020

Public Version Number

5

DI Record Publish Date

March 01, 2016

Additional Identifiers

Package DI Number

28717648014028

Quantity per Package

5

Contains DI Package

08717648014024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"ABBOTT VASCULAR 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. 964
3 A medical device with high risk that requires premarket approval 775