Duploject Easy Prep 1501250

GUDID 50085412095832

Fibrin Sealant Preparation and Application System for the preparation and application of Tisseel Two-component Fibrin Sealant (2 mL Kit)

BAXTER INTERNATIONAL INC.

Open-surgery adhesive/sealant applicator, dual-channel
Primary Device ID50085412095832
NIH Device Record Key7adb8e1c-8d19-476e-812e-f769e54eba23
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuploject Easy Prep
Version Model Number1501250
Catalog Number1501250
Company DUNS005146311
Company NameBAXTER INTERNATIONAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com

Device Dimensions

Total Volume2 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100085412095837 [Primary]
GS150085412095832 [Package]
Contains: 00085412095837
Package: CASE [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, piston

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Duploject Easy Prep]

50085412095849Fibrin Sealant Preparation and Application System for the preparation and application of Tisseel
50085412095832Fibrin Sealant Preparation and Application System for the preparation and application of Tisseel
50085412095634Fibrin Sealant Preparation and Application System for the preparation and application of Tisseel

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