Ultra-Care Insulin Syringe 31G 5/16" 0.5 CC 100 Ct

GUDID 00372217007074

Ultra-Care Insulin Syringe 31G 5/16" 0.5 CC 100 Ct

ARISE MEDICAL LLC

Insulin syringe/needle, basic

• Primary Device ID: 00372217007074
• NIH Device Record Key: 9a44655c-5c26-4ca5-abcc-8fab890a7978
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra-Care Insulin Syringe 31G 5/16" 0.5 CC 100 Ct
• Version Model Number: 240405
• Company DUNS: 081149273
• Company Name: ARISE MEDICAL LLC
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00372217007074 [Primary]
GS1	00372217007326 [Package]; Package: Case [5 Units]; In Commercial Distribution
GS1	00372217007579 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162180

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-20
• Device Publish Date: 2018-11-29

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