Occlutech® Steerable Guiding Sheath - Steerable Guiding Sheath, 14F - Oscor Inc.

Duns Number:101835833

Device Description: Steerable Guiding Sheath, 14F

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More Product Details

Catalog Number

51GS014

Brand Name

Occlutech® Steerable Guiding Sheath

Version/Model Number

51GS014

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 11, 2019

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

K120459

Product Code Details

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Device Record Status

Public Device Record Key

64ad6282-f4d9-4026-9246-b4a8f6c481ea

Public Version Date

December 22, 2021

Public Version Number

8

DI Record Publish Date

November 28, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OSCOR INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 592
3 A medical device with high risk that requires premarket approval 16