StatStrip 41224

GUDID 00385480412247

Safety Lancets 28-Gauge 100 Pack Boxed

NOVA BIOMEDICAL CORPORATION

Metabolic profile clinical chemistry analyser IVD, portable, semi-automated

• Primary Device ID: 00385480412247
• NIH Device Record Key: 9792eb50-aeba-4913-8f21-796f4200015b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StatStrip
• Version Model Number: Lancet
• Catalog Number: 41224
• Company DUNS: 070617139
• Company Name: NOVA BIOMEDICAL CORPORATION
• Device Count: 100
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)545-6682
• Email: info@novabio.com
• Phone: +1(800)545-6682
• Email: info@novabio.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385480412247 [Primary]
GS1	00385489412248 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061830

FDA Product Code

• CGA: GLUCOSE OXIDASE, GLUCOSE

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: 2016-09-20

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