FLOSEAL HEMOSTATIC MATRIX ADS202105

GUDID 50085412827952

Floseal with Recothrom - 5mL

BAXTER HEALTHCARE CORPORATION

Collagen haemostatic agent, non-antimicrobial
Primary Device ID50085412827952
NIH Device Record Key50b034e0-7d03-4db3-ac09-5673887ca475
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLOSEAL HEMOSTATIC MATRIX
Version Model NumberADS202105
Catalog NumberADS202105
Company DUNS628013963
Company NameBAXTER HEALTHCARE CORPORATION
Device Count6
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 Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com
Phone+1(888)229-0001
EmailUS-MEDINFO_MEDPRODUCTS@baxter.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100085412827957 [Primary]
GS150085412827952 [Package]
Contains: 00085412827957
Package: CASE [6 Units]
In Commercial Distribution
GS170085412827956 [Unit of Use]

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 Date2022-04-26
Device Publish Date2022-04-18

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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