inControl/UltiCare

GUDID 20412206068946

6mm inControl/UltiCare Pen Needle UltiGuard

H. E. BUTT GROCERY COMPANY

Autoinjector needle Autoinjector needle

• Primary Device ID: 20412206068946
• NIH Device Record Key: acc283bf-e296-4d57-bc76-fbb2d8e0ca04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: inControl/UltiCare
• Version Model Number: 898831
• Company DUNS: 007924756
• Company Name: H. E. BUTT GROCERY COMPANY
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00357515710048 [Unit of Use]
GS1	20412206068946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100812

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-18

On-Brand Devices [inControl/UltiCare]

• 20412206069172: 8mm inControl/UltiCare Pen Needle UltiGuard
• 20412206068946: 6mm inControl/UltiCare Pen Needle UltiGuard
• 20041220606911: 8mm inControl/UltiCare Pen Needle UltiGuard
• 00357515710048: InControl 6mm pen needle UltiGuard