SURGIFLO™ Hemostatic Matrix Kit with Thrombin

GUDID 25712123000643

Ferrosan Medical Devices A/S

Gelatin haemostatic agent

• Primary Device ID: 25712123000643
• NIH Device Record Key: 0efb7bed-e3d6-4241-a48b-929971d5f123
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGIFLO™ Hemostatic Matrix Kit with Thrombin
• Version Model Number: SF2995
• Company DUNS: 305175344
• Company Name: Ferrosan Medical Devices A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15712123000646 [Primary]
GS1	25712123000643 [Package]; Contains: 15712123000646; Package: Box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P990004

FDA Product Code

• LMF: Agent, Absorbable Hemostatic, Collagen Based

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: 2026-01-13
• Device Publish Date: 2026-01-05

Devices Manufactured by Ferrosan Medical Devices A/S

• 25712123000643 - SURGIFLO™ Hemostatic Matrix Kit with Thrombin: 2026-01-13
• 25712123000643 - SURGIFLO™ Hemostatic Matrix Kit with Thrombin: 2026-01-13
• 15712123000141 - SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Oral Sponge: 2019-12-24
• 15712123000158 - SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.: 2019-12-24
• 15712123000172 - SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.: 2019-12-24
• 15712123000189 - SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.: 2019-12-24
• 15712123000202 - SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.: 2019-12-24
• 15712123000226 - SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Hemorrhoidectomy Sponge: 2019-12-24
• 15712123000240 - SURGIFOAM® Absorbable Gelatin Powder: 2019-12-24