Sure Comfort 22-8010

GUDID 00786227801094

1mL 28G 12.7mm Single use disposable insulin syringe with needle. Includes 100 sterile syringes in convenient 10 pack bags.

ALLISON MEDICAL, INC.

Insulin syringe/needle, basic Insulin syringe/needle, basic

• Primary Device ID: 00786227801094
• NIH Device Record Key: 43fab361-4da2-4a30-a75d-d7359d7a3f92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sure Comfort
• Version Model Number: 22-8010
• Catalog Number: 22-8010
• Company DUNS: 825097264
• Company Name: ALLISON MEDICAL, INC.
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-886-1618
• Email: info@allisonmedical.com
• Phone: 1-800-886-1618
• Email: info@allisonmedical.com

Device Dimensions

• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00786227801032 [Unit of Use]
GS1	00786227801056 [Primary]
GS1	00786227801070 [Package]; Contains: 00786227801056; Package: Case [5 Units]; In Commercial Distribution
GS1	00786227801094 [Package]; Contains: 00786227801056; Package: Master Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152879

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-03

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