GUDID 00385640023900

SUMMIT MEDICAL, INC.

Ear wick, non-biodegradable

• Primary Device ID: 00385640023900
• NIH Device Record Key: 0bfd8803-d427-4c31-98e5-4baafd3c69c0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: OT-5201-50
• Company DUNS: 965484699
• Company Name: SUMMIT MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385640023900 [Primary]
GS1	10385640023907 [Package]; Package: Box [50 Units]; In Commercial Distribution

FDA Product Code

• KCN: Ear Wick

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: 2018-03-29
• Device Publish Date: 2016-10-11

Devices Manufactured by SUMMIT MEDICAL, INC.

• 00385640089746 - INSTRUSAFE: 2026-01-19
• 00385640089753 - INSTRUSAFE: 2026-01-19
• 00385640089722 - INSTRUSAFE: 2026-01-16
• 00385640089739 - INSTRUSAFE: 2026-01-16
• 00385640089715 - INSTRUSAFE: 2026-01-15
• 00385640089616 - INSTRUSAFE: 2026-01-14
• 00385640089623 - INSTRUSAFE: 2026-01-14
• 00385640089630 - INSTRUSAFE: 2026-01-14