InControl/UltiCare

GUDID 00357515710048

InControl 6mm pen needle UltiGuard

H. E. BUTT GROCERY COMPANY

Autoinjector needle

• Primary Device ID: 00357515710048
• NIH Device Record Key: 580d5ad7-e48f-4599-9848-4d47bf4acd76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InControl/UltiCare
• Version Model Number: 919040
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00200412206780 [Primary]
GS1	00357515710048 [Unit of Use]

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: 1
• Public Version Date: 2023-04-04
• Device Publish Date: 2023-03-27

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