Adelante Peel-Away Introducer Set - Peel-Away Introducer Set, 6F - Oscor Inc.

Duns Number:101835833

Device Description: Peel-Away Introducer Set, 6F

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More Product Details

Catalog Number

AP06045P

Brand Name

Adelante Peel-Away Introducer Set

Version/Model Number

AP06045P

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

K073100,K073100

Product Code Details

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Device Record Status

Public Device Record Key

84d748e6-5209-46a7-91df-3ff09fe2c370

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

November 15, 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