FLOSEAL HEMOSTATIC MATRIX ADS201845

GUDID 50085412639609

FLOSEAL Hemostatic Matrix, 10mL

BAXTER HEALTHCARE CORPORATION

Collagen haemostatic agent
Primary Device ID50085412639609
NIH Device Record Key101b306f-5a7b-4f0a-9c8e-b15fd5c15d02
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLOSEAL HEMOSTATIC MATRIX
Version Model NumberADS201845
Catalog NumberADS201845
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 Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(888)229-0001
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM

Device Dimensions

Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100085412639604 [Primary]
GS150085412639609 [Package]
Contains: 00085412639604
Package: CASE [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PMXAbsorbable collagen hemostatic agent with thrombin

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-07
Device Publish Date2019-07-30

On-Brand Devices [FLOSEAL HEMOSTATIC MATRIX]

50085412096129Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to h
00085412096117Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to h
50085412096105Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to h
00085412096094Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to h
50085412656309Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to h
50085412639609FLOSEAL Hemostatic Matrix, 10mL
50085412639593FLOSEAL Hemostatic Matrix, 5ml
50085412827952Floseal with Recothrom - 5mL
50085412827891Floseal with Recothrom - 10mL.
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