STA® - Thrombin 10

GUDID 13607450006695

DIAGNOSTICA STAGO

Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting

• Primary Device ID: 13607450006695
• NIH Device Record Key: 3a87e705-b045-44c7-ba62-a3db6efb685e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STA® - Thrombin 10
• Version Model Number: 00669
• Company DUNS: 262277122
• Company Name: DIAGNOSTICA STAGO
• Device Count: 12
• 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: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607450006698 [Unit of Use]
GS1	13607450006695 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K884384

FDA Product Code

• GJA: TEST, THROMBIN TIME

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

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• 03607450589894 - STA Compact Max® (with cap piercing option): 2022-09-16
• 03607450589900 - STA Compact Max®: 2022-09-16
• 03607450590104 - STA R Max® (with cap piercing option): 2022-09-16
• 03607450590135 - STA R Max®: 2022-09-16
• 03607450590265 - STA R Max®: 2022-09-16