SURGIFLO® Hemostatic Matrix Kit with Thrombin

GUDID 15712123000325

Ferrosan Medical Devices A/S

Gelatin haemostatic agent

• Primary Device ID: 15712123000325
• NIH Device Record Key: 963cec92-60d4-4dfd-99ae-8216d5262e64
• Commercial Distribution Discontinuation: 2017-11-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SURGIFLO® Hemostatic Matrix Kit with Thrombin
• Version Model Number: 2993
• 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: false
• Device Combination Product: false
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15712123000325 [Primary]
GS1	25712123000322 [Package]; Package: Box [6 Units]; Discontinued: 2017-11-30; Not 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-08
• Device Publish Date: 2014-09-20

On-Brand Devices [SURGIFLO® Hemostatic Matrix Kit with Thrombin]

• 15712123000325: 2993
• 15712123000288: 2994