FLOSEAL HEMOSTATIC MATRIX ADS202105

GUDID 50085412827952

Floseal with Recothrom - 5mL

BAXTER HEALTHCARE CORPORATION

Collagen haemostatic agent, non-antimicrobial

• Primary Device ID: 50085412827952
• NIH Device Record Key: 50b034e0-7d03-4db3-ac09-5673887ca475
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLOSEAL HEMOSTATIC MATRIX
• Version Model Number: ADS202105
• Catalog Number: ADS202105
• Company DUNS: 628013963
• Company Name: BAXTER HEALTHCARE CORPORATION
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(888)229-0001
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412827957 [Primary]
GS1	50085412827952 [Package]; Contains: 00085412827957; Package: CASE [6 Units]; In Commercial Distribution
GS1	70085412827956 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P990009

FDA Product Code

• PMX: Absorbable collagen hemostatic agent with thrombin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-26
• Device Publish Date: 2022-04-18

On-Brand Devices [FLOSEAL HEMOSTATIC MATRIX]

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