Pencylcap needle P1400063

GUDID 04046964756290

Needles for use with compatible needle-based injection systems for subcutaneous injection of fluid drug products. Single packed, sterile. For single use only. Non-pyrogenic.

EMD Serono, Inc.

Autoinjector needle

• Primary Device ID: 04046964756290
• NIH Device Record Key: 29caa12c-f056-4fd7-a13e-051dadb39456
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pencylcap needle
• Version Model Number: U1944111
• Catalog Number: P1400063
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046955198610 [Unit of Use]
GS1	04046964756290 [Primary]
GS1	04046964756900 [Package]; Package: [12 Units]; 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: 2
• Public Version Date: 2024-09-11
• Device Publish Date: 2018-10-19

Devices Manufactured by EMD Serono, Inc.

• 04046964756290 - Pencylcap needle: 2024-09-11Needles for use with compatible needle-based injection systems for subcutaneous injection of fluid drug products. Single packed, sterile. For single use only. Non-pyrogenic.
• 04046964756290 - Pencylcap needle: 2024-09-11 Needles for use with compatible needle-based injection systems for subcutaneous injection of fluid drug products. Single packed,
• 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.