INSULIN PEN NEEDLE HWIPN3108

GUDID 16958697605866

A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.

ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD

Autoinjector needle

• Primary Device ID: 16958697605866
• NIH Device Record Key: e43d29b7-c026-4ddc-bde4-52610faf7305
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSULIN PEN NEEDLE
• Version Model Number: 31G x 8MM
• Catalog Number: HWIPN3108
• Company DUNS: 543007373
• Company Name: ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
• Device Count: 1
• 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: true
• 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	06958697605869 [Primary]
GS1	16958697605866 [Package]; Contains: 06958697605869; Package: [100 Units]; In Commercial Distribution
GS1	26958697605863 [Package]; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133058

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: 2022-03-14
• Device Publish Date: 2022-03-04

On-Brand Devices [INSULIN PEN NEEDLE ]

• 16958697605873: A device designed for the parenteral administration of a drug contained in a cartridge that form
• 16958697605866: A device designed for the parenteral administration of a drug contained in a cartridge that form
• 16958697605859: A device designed for the parenteral administration of a drug contained in a cartridge that form
• 16958697605842: A device designed for the parenteral administration of a drug contained in a cartridge that form
• 16958697605828: A device designed for the parenteral administration of a drug contained in a cartridge that form
• 26958697605924: A device designed for the parenteral administration of a drug contained in a cartridge that form
• 26958697605917: A device designed for the parenteral administration of a drug contained in a cartridge that form
• 26958697605900: A device designed for the parenteral administration of a drug contained in a cartridge that form
• 26958697605894: A device designed for the parenteral administration of a drug contained in a cartridge that form
• 26958697605887: A device designed for the parenteral administration of a drug contained in a cartridge that form