US DIAGNOSTICS Pen Needles, 31G 5MM, 50ea

GUDID 20857513006364

US DIAGNOSTICS Pen Needles are sterile, non-toxic, non-pyrogenic, single-use injection needles intended for use with all major brands of injection pens. This needle is a device for subcutaneous injection of medicines used for pen type of insulin syringe as subcutaneous injectables.

YIDOBIO Inc.

Autoinjector needle

• Primary Device ID: 20857513006364
• NIH Device Record Key: 4d0bcb46-7ce3-47e7-b0b7-4fd0332aa93a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: US DIAGNOSTICS Pen Needles, 31G 5MM, 50ea
• Version Model Number: 100098
• Company DUNS: 689512763
• Company Name: YIDOBIO Inc.
• Device Count: 50
• 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: true

Device Dimensions

• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857513006360 [Primary]
GS1	10857513006367 [Package]; Contains: 00857513006360; Package: Middle Box [20 Units]; In Commercial Distribution
GS1	20857513006364 [Package]; Contains: 10857513006367; Package: Outer Box [5 Units]; In Commercial Distribution
GS1	90857513006363 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160575

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-24

Devices Manufactured by YIDOBIO Inc.

• 20857513006272 - US DIAGNOSTICS Pen Needles, 31G x 5MM: 2018-07-06 US DIAGNOSTICS Pen Needles are sterile, non-toxic, non-pyrogenic, single-use injection needles intended for use with all major b
• 20857513006289 - US DIAGNOSTICS Pen Needles, 31G x 6MM: 2018-07-06 US DIAGNOSTICS Pen Needles are sterile, non-toxic, non-pyrogenic, single-use injection needles intended for use with all major b
• 20857513006296 - US DIAGNOSTICS Pen Needles, 31G x 8MM: 2018-07-06 US DIAGNOSTICS Pen Needles are sterile, non-toxic, non-pyrogenic, single-use injection needles intended for use with all major b
• 20857513006302 - US DIAGNOSTICS Pen Needles, 32G x 4MM: 2018-07-06 US DIAGNOSTICS Pen Needles are sterile, non-toxic, non-pyrogenic, single-use injection needles intended for use with all major b
• 20857513006333 - US DIAGNOSTICS Pen Needles, 32G x 4MM, 50ea: 2018-07-06 US DIAGNOSTICS Pen Needles are sterile, non-toxic, non-pyrogenic, single-use injection needles intended for use with all major b
• 20857513006340 - US DIAGNOSTICS Pen Needles, 32G x 5MM, 50ea: 2018-07-06 US DIAGNOSTICS Pen Needles are sterile, non-toxic, non-pyrogenic, single-use injection needles intended for use with all major b
• 20857513006357 - US DIAGNOSTICS Pen Needles, 32G x 6MM, 50ea: 2018-07-06 US DIAGNOSTICS Pen Needles are sterile, non-toxic, non-pyrogenic, single-use injection needles intended for use with all major b
• 20857513006364 - US DIAGNOSTICS Pen Needles, 31G 5MM, 50ea: 2018-07-06US DIAGNOSTICS Pen Needles are sterile, non-toxic, non-pyrogenic, single-use injection needles intended for use with all major brands of injection pens. This needle is a device for subcutaneous injection of medicines used for pen type of insulin syringe as subcutaneous injectables.
• 20857513006364 - US DIAGNOSTICS Pen Needles, 31G 5MM, 50ea: 2018-07-06 US DIAGNOSTICS Pen Needles are sterile, non-toxic, non-pyrogenic, single-use injection needles intended for use with all major b