Unfine SafeControl

GUDID 00384707940020

Unifine SafeControl pen needles, 4mm x 32G

OWEN MUMFORD USA INCORPORATED

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

• Primary Device ID: 00384707940020
• NIH Device Record Key: 610df9a3-f477-4ddf-80c6-4d25e1c0eb00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unfine SafeControl
• Version Model Number: AN 7940
• Company DUNS: 803401454
• Company Name: OWEN MUMFORD USA INCORPORATED
• 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: true
• OTC Over-The-Counter: true

Device Dimensions

• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384707940006 [Unit of Use]
GS1	00384707940013 [Primary]
GS1	00384707940020 [Package]; Contains: 00384707940013; Package: Sleeve [6 Units]; In Commercial Distribution
GS1	00384707940037 [Package]; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210399

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: 2023-07-03
• Device Publish Date: 2023-06-23

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