Sure Comfort 24-1010

GUDID 00786227101057

29G x 1/2" (12.7mm) Single use disposable pen needle for use with most insulin delivery systems (Insulin Pen). Includes 100 sterile needles individually wrapped.

ALLISON MEDICAL, INC.

Autoinjector needle

• Primary Device ID: 00786227101057
• NIH Device Record Key: e61d2ba9-1b9f-4581-a68f-d7c375151c46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sure Comfort
• Version Model Number: 24-1010
• Catalog Number: 24-1010
• Company DUNS: 825097264
• Company Name: ALLISON MEDICAL, INC.
• 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: 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: false
• 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

• Length: 12.7 Millimeter
• Length: 12.7 Millimeter
• Length: 12.7 Millimeter
• Length: 12.7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00786227101057 [Primary]
GS1	00786227101071 [Package]; Package: Case [12 Units]; In Commercial Distribution
GS1	00786227101095 [Package]; Contains: 00786227101071; Package: Master Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152877

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

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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