STA R Max® (with cap piercing option)

GUDID 03607450590104

DIAGNOSTICA STAGO

Coagulation analyser IVD, laboratory

• Primary Device ID: 03607450590104
• NIH Device Record Key: dcdcf756-fcf4-436d-9c2a-bf5031712dae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STA R Max® (with cap piercing option)
• Version Model Number: 59010
• Company DUNS: 262277122
• Company Name: DIAGNOSTICA STAGO
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607450590104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082675

FDA Product Code

• JPA: SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-09-16
• Device Publish Date: 2016-09-15

On-Brand Devices [STA R Max® (with cap piercing option)]

• 03607450590272: 59027
• 03607450590104: 59010