SureFlex Steerable Guiding Sheath - SureFlex Steerable Sheath; Transseptal Dilator; - Baylis Médicale Cie Inc

Duns Number:249225954

Device Description: SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire

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More Product Details

Catalog Number

NA

Brand Name

SureFlex Steerable Guiding Sheath

Version/Model Number

TSK85-32-BD-71M

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

DYB

Product Code Name

Introducer, Catheter

Device Record Status

Public Device Record Key

1b53c0ea-d1ea-4ce7-bfd6-16bd738e5ef5

Public Version Date

March 28, 2022

Public Version Number

3

DI Record Publish Date

April 12, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BAYLIS MÉDICALE CIE INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1139