Unifine OTC

GUDID 00761059650027

Unifine OTC Pen Needle, 5mm x 31G, 100 ct

OWEN MUMFORD USA INCORPORATED

Autoinjector needle

• Primary Device ID: 00761059650027
• NIH Device Record Key: d0091489-3b49-4a3e-a1a3-cdc62d6bb58c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unifine OTC
• Version Model Number: AN 3650
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com

Device Dimensions

• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384703550001 [Unit of Use]
GS1	00761059650003 [Primary]
GS1	00761059650027 [Package]; Contains: 00761059650003; Package: Sleeve [10 Units]; In Commercial Distribution
GS1	00761059650034 [Package]; Contains: 00761059650003; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152339

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: 2025-02-24
• Device Publish Date: 2025-02-14

On-Brand Devices [Unifine OTC]

• 00761059651031: Unifine OTC Pen Needle, 5mm x 31G, 50 ct
• 00761059650027: Unifine OTC Pen Needle, 5mm x 31G, 100 ct
• 00761059641032: Unifine OTC Pen Needles 4mm x 32G 50 ct
• 00761059640028: Unifine OTC Pen Needle 4mm x 32G 100 ct