Pentips 1st Tier

GUDID 00761059429029

Pentips 1st Tier pen needles Original, 12mm x 29G

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

• Primary Device ID: 00761059429029
• NIH Device Record Key: ee143a78-2ff1-48dc-9c58-aba0ce3400b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pentips 1st Tier
• Version Model Number: AN 3429FT
• 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: 29 Gauge
• Length: 12 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12 Millimeter
• Needle Gauge: 29 Gauge
• Length: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384703429000 [Unit of Use]
GS1	00761059429012 [Primary]
GS1	00761059429029 [Package]; Contains: 00761059429012; Package: Sleeve [10 Units]; In Commercial Distribution
GS1	00761059429036 [Package]; Package: Case [5 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: 2023-07-03
• Device Publish Date: 2023-06-23

On-Brand Devices [Pentips 1st Tier]

• 00761059490029: Pentips 1st Tier pen needles, 6mm x 31G
• 00761059450023: Pentips 1st Tier pen needles Mini, 5mm x 31G
• 00761059440024: Pentips 1st tier pen needles, 4mm x 32G
• 00761059430025: Pentips 1st Tier pen needles Short, 8mm x 31G
• 00761059429029: Pentips 1st Tier pen needles Original, 12mm x 29G