Coseal Surgical Sealant Extended Applicator 934034

GUDID 00085412083339

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 Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel
Primary Device ID00085412083339
NIH Device Record Keyc7219c2b-9e8a-430f-829c-dd2c235b2227
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoseal Surgical Sealant Extended Applicator
Version Model Number934034
Catalog Number934034
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

Device Dimensions

Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 Centimeter
Length22 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)

Device Identifiers

Device Issuing AgencyDevice ID
GS100085412083339 [Primary]
GS150085412083334 [Package]
Package: CASE [10 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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