Eclipse Hypodermic Needle - 18G

GUDID 00853602008604

Eclipse 18 Gauge Venting Needle - 18G x 1"; sterilized and individually packaged for single patient use. Venting needle is a component within the Eclipse PRP 22mL Patient Kit.

ECLIPSE

Hypodermic needle, single-use

• Primary Device ID: 00853602008604
• NIH Device Record Key: a3209455-573d-4c61-a8d1-26c295b84338
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eclipse Hypodermic Needle - 18G
• Version Model Number: 50PRP2500-N18gx25mm
• Company DUNS: 969752364
• Company Name: ECLIPSE
• 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: 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: 800-759-6876
• Email: info@eclipsemed.com
• Phone: 800-759-6876
• Email: info@eclipsemed.com
• Phone: 800-759-6876
• Email: info@eclipsemed.com
• Phone: 800-759-6876
• Email: info@eclipsemed.com
• Phone: 800-759-6876
• Email: info@eclipsemed.com
• Phone: 800-759-6876
• Email: info@eclipsemed.com
• Phone: 800-759-6876
• Email: info@eclipsemed.com
• Phone: 800-759-6876
• Email: info@eclipsemed.com
• Phone: 800-759-6876
• Email: info@eclipsemed.com
• Phone: 800-759-6876
• Email: info@eclipsemed.com
• Phone: 800-759-6876
• Email: info@eclipsemed.com
• Phone: 800-759-6876
• Email: info@eclipsemed.com
• Phone: 800-759-6876
• Email: info@eclipsemed.com
• Phone: 800-759-6876
• Email: info@eclipsemed.com
• Phone: 800-759-6876
• Email: info@eclipsemed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853602008604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172938

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: 2022-01-19
• Device Publish Date: 2022-01-11

Devices Manufactured by ECLIPSE

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• 00853602008604 - Eclipse Hypodermic Needle - 18G: 2022-01-19Eclipse 18 Gauge Venting Needle - 18G x 1"; sterilized and individually packaged for single patient use. Venting needle is a component within the Eclipse PRP 22mL Patient Kit.
• 00853602008604 - Eclipse Hypodermic Needle - 18G: 2022-01-19 Eclipse 18 Gauge Venting Needle - 18G x 1"; sterilized and individually packaged for single patient use. Venting needle is a com
• 00853602008611 - Eclipse Hypodermic Needle - 30G: 2022-01-19 Eclipse 30G Hypodermic Needle - 30G x 0.5"; sterilized and individually packaged for single patient use.
• 10853602008458 - Eclipse DermaFlex MicroCannula: 2021-03-31 DermaFlex Microcannula 22G/60mm + 21G/25mm
• 00853602008468 - Eclipse DermaFlex MicroCannula: 2021-03-31 DermaFlex Microcannula 22G/70mm + 21G/25mm Pilot
• 10853602008472 - Eclipse DermaFlex MicroCannula: 2021-03-31 DermaFlex Microcannula 25G/40mm + 23G/25mm Pilot
• 10853602008489 - Eclipse DermaFlex MicroCannula: 2021-03-31 DermaFlex Microcannula 25G/50mm + 23G/25mm Pilot