InControl/UltiCare

GUDID 00357515710048

InControl 6mm pen needle UltiGuard

H. E. BUTT GROCERY COMPANY

Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle 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