CORE-INJECTOR

GUDID 08800035704865

INCORE CO., LTD

General-purpose endoscopic needle, single-use

• Primary Device ID: 08800035704865
• NIH Device Record Key: 9a7f1e13-5952-4edf-8d97-afeb34dddd5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORE-INJECTOR
• Version Model Number: JW-IJ2318
• Company DUNS: 690405835
• Company Name: INCORE 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +821065095009
• Email: mktg01@incoremedi.com
• Phone: +821065095009
• Email: mktg01@incoremedi.com
• Phone: +821065095009
• Email: mktg01@incoremedi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800035704865 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221054

FDA Product Code

• FBK: Endoscopic Injection Needle, Gastroenterology-Urology

Sterilization

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

[08800035704865]

Ethylene Oxide

[08800035704865]

Ethylene Oxide

[08800035704865]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-16
• Device Publish Date: 2026-02-06

On-Brand Devices [CORE-INJECTOR]

• 08800035704896: JW-IJ2518
• 08800035704889: JW-IJ2516
• 08800035704872: JW-IJ2512
• 08800035704865: JW-IJ2318
• 08800035704858: JW-IJ2316
• 08800035704841: JW-IJ2312
• 08800035704728: JW-IJ2523
• 08800035704711: JW-IJ2323