GUDID 00385640023894

SUMMIT MEDICAL, INC.

Ear wick, non-biodegradable

• Primary Device ID: 00385640023894
• NIH Device Record Key: 25ec0a25-1d4f-4b83-a1b8-6c8f1d51c9a6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: OT-5200-25
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385640023894 [Primary]
GS1	10385640023891 [Package]; Package: Box [25 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.

• 00385640084604 - INSTRUSAFE: 2024-12-30
• 00385640084611 - INSTRUSAFE: 2024-12-30
• 00385640084628 - INSTRUSAFE: 2024-12-30
• 00385640084635 - INSTRUSAFE: 2024-12-30
• 00385640084642 - INSTRUSAFE: 2024-12-30
• 00385640084659 - INSTRUSAFE: 2024-12-30
• 00385640084666 - INSTRUSAFE: 2024-12-30
• 00385640084673 - INSTRUSAFE: 2024-12-30