Coseal Surgical Sealant Replacement Applicator 934033

GUDID 50085412083327

The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical Sealant Components.

BAXTER HEALTHCARE CORPORATION

Open-surgery adhesive/sealant applicator, dual-channel
Primary Device ID50085412083327
NIH Device Record Key88949064-0dcd-4932-a0db-18094932908e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoseal Surgical Sealant Replacement Applicator
Version Model Number934033
Catalog Number934033
Company DUNS628013963
Company NameBAXTER HEALTHCARE CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Dimensions

Height7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter
Length7 Centimeter
Height7 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (approximately 25 degrees celsius)

Device Identifiers

Device Issuing AgencyDevice ID
GS100085412083322 [Primary]
GS150085412083327 [Package]
Contains: 00085412083322
Package: CASE [5 Units]
In Commercial Distribution

FDA Product Code

NBESealant,Polymerizing

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-10-09

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