one.click needle 16440EMD

GUDID 04046963412791

Needles for one.click® auto-injector. Single packed, sterile. For single use only. Non-pyrogenic.

EMD SERONO, INC.

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: 04046963412791
• NIH Device Record Key: 96c5eea0-07ac-4129-8a66-62de464e374c
• Commercial Distribution Discontinuation: 2023-10-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: one.click needle
• Version Model Number: U1244101
• Catalog Number: 16440EMD
• Company DUNS: 088514898
• Company Name: EMD SERONO, INC.
• 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: false

Customer Support Contacts

• Phone: 1-800-582-7989
• Email: xx@xx.xx
• Phone: 1-800-582-7989
• Email: xx@xx.xx
• Phone: 1-800-582-7989
• Email: xx@xx.xx
• Phone: 1-800-582-7989
• Email: xx@xx.xx
• Phone: 1-800-582-7989
• Email: xx@xx.xx
• Phone: 1-800-582-7989
• Email: xx@xx.xx
• Phone: 1-800-582-7989
• Email: xx@xx.xx
• Phone: 1-800-582-7989
• Email: xx@xx.xx
• Phone: 1-800-582-7989
• Email: xx@xx.xx
• Phone: 1-800-582-7989
• Email: xx@xx.xx
• Phone: 1-800-582-7989
• Email: xx@xx.xx
• Phone: 1-800-582-7989
• Email: xx@xx.xx
• Phone: 1-800-582-7989
• Email: xx@xx.xx
• Phone: 1-800-582-7989
• Email: xx@xx.xx
• Phone: 1-800-582-7989
• Email: xx@xx.xx
• Phone: 1-800-582-7989
• Email: xx@xx.xx
• Phone: 1-800-582-7989
• Email: xx@xx.xx
• Phone: 1-800-582-7989
• Email: xx@xx.xx

Device Dimensions

• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046963412784 [Unit of Use]
GS1	04046963412791 [Primary]
GS1	04046963413804 [Package]; Package: [12 Units]; Not in Commercial Distribution

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-10-03
• Device Publish Date: 2016-08-26

Devices Manufactured by EMD SERONO, INC.

• 04046963412791 - one.click needle: 2023-10-03Needles for one.click® auto-injector. Single packed, sterile. For single use only. Non-pyrogenic.
• 04046963412791 - one.click needle: 2023-10-03 Needles for one.click® auto-injector. Single packed, sterile. For single use only. Non-pyrogenic.
• 04046963413880 - Serofine needles 29 G: 2019-04-19 Needles for easypod auto-injector. Single packed, sterile. For single use only. Non-pyrogenic.
• 04046963414047 - Serofine needles 30G: 2019-04-19 Needles for easypod auto-injector. Single packed, sterile. For single use only. Non-pyrogenic.
• 04054839025792 - one.click: 2019-04-19 one.click is a mechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rNDA origin]) in c
• 04054839025860 - easypod: 2019-04-19 easypod is an electromechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rDNA origin]
• 04054839025808 - Rebiject II: 2018-03-29 Rebiject II® autoinjector is a device intended for automating subcutaneous injection of Rebif® (interferon beta-1a) in pre-fil
• 04054839025914 - Clip-on Spacers for Rebif: 2018-03-29 Titration Clip for Dose Titration using Rebif® 22 mcg or 44 mcg Pre-filled Syringe.