Duploject Easy Prep - Fibrin Sealant Preparation and Application System - BAXTER INTERNATIONAL INC.

Duns Number:005146311

Device Description: Fibrin Sealant Preparation and Application System for the preparation and application of T Fibrin Sealant Preparation and Application System for the preparation and application of Tisseel Two-component Fibrin Sealant (4 mL Kit)

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More Product Details

Catalog Number

1501251

Brand Name

Duploject Easy Prep

Version/Model Number

1501251

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"

Yes

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

K020666,K020666

Product Code Details

Product Code

FMF

Product Code Name

Syringe, piston

Device Record Status

Public Device Record Key

e03c9863-7392-40d8-aeac-823444d8a485

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

50085412095849

Quantity per Package

6

Contains DI Package

00085412095844

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"BAXTER INTERNATIONAL 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. 358