LiteTouch

GUDID 00732671071811

MediCore's LiteTouch Brand Luer Lock Hypodermic Syringe w/o Needle

AMITY HOLDINGS, LLC

General-purpose syringe, single-use

• Primary Device ID: 00732671071811
• NIH Device Record Key: fb1b53cc-b488-4c17-973b-01380643791a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LiteTouch
• Version Model Number: 718L
• Company DUNS: 016069284
• Company Name: AMITY HOLDINGS, LLC
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 800 327 8894
• Email: wconety@medicore.com
• Phone: 800 327 8894
• Email: wconety@medicore.com

Device Dimensions

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732671071811 [Primary]
GS1	10732671171815 [Package]; Package: Chipboard Carton [100 Units]
GS1	20732671271819 [Package]; Contains: 10732671171815; Package: Corrogate Carton [6 Units]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132553

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: 5
• Public Version Date: 2019-06-17
• Device Publish Date: 2016-09-22

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