X-celeratorTM - 103-0602-350 XCELERATOR14 GWIRE - Micro Therapeutics, Inc.

Duns Number:826110710

Device Description: 103-0602-350 XCELERATOR14 GWIRE

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More Product Details

Catalog Number

-

Brand Name

X-celeratorTM

Version/Model Number

103-0602-350

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

80d2f781-8fdd-466d-adc8-5ee22fe0adb0

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

April 02, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICRO THERAPEUTICS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1759
3 A medical device with high risk that requires premarket approval 562