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
Primary Device ID04046963412791
NIH Device Record Key96c5eea0-07ac-4129-8a66-62de464e374c
Commercial Distribution Discontinuation2023-10-02
Commercial Distribution StatusNot in Commercial Distribution
Brand Nameone.click needle
Version Model NumberU1244101
Catalog Number16440EMD
Company DUNS088514898
Company NameEMD SERONO, INC.
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx
Phone1-800-582-7989
Emailxx@xx.xx

Device Dimensions

Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge
Needle Gauge29 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS104046963412784 [Unit of Use]
GS104046963412791 [Primary]
GS104046963413804 [Package]
Package: [12 Units]
Not in Commercial Distribution

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-10-03
Device Publish Date2016-08-26

Devices Manufactured by EMD SERONO, INC.

04046964756290 - Pencylcap needle2024-09-11 Needles for use with compatible needle-based injection systems for subcutaneous injection of fluid drug products. Single packed,
04046963412791 - one.click needle2023-10-03Needles for one.click® auto-injector. Single packed, sterile. For single use only. Non-pyrogenic.
04046963412791 - one.click needle2023-10-03 Needles for one.click® auto-injector. Single packed, sterile. For single use only. Non-pyrogenic.
04046963413880 - Serofine needles 29 G2019-04-19 Needles for easypod auto-injector. Single packed, sterile. For single use only. Non-pyrogenic.
04046963414047 - Serofine needles 30G2019-04-19 Needles for easypod auto-injector. Single packed, sterile. For single use only. Non-pyrogenic.
04054839025792 - one.click2019-04-19 one.click is a mechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rNDA origin]) in c
04054839025860 - easypod2019-04-19 easypod is an electromechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rDNA origin]
04054839025808 - Rebiject II2018-03-29 Rebiject II® autoinjector is a device intended for automating subcutaneous injection of Rebif® (interferon beta-1a) in pre-fil
04054839025914 - Clip-on Spacers for Rebif2018-03-29 Titration Clip for Dose Titration using Rebif® 22 mcg or 44 mcg Pre-filled Syringe.

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