GUDID 00385640025607

SUMMIT MEDICAL, INC.

Intranasal splint, non-biodegradable

• Primary Device ID: 00385640025607
• NIH Device Record Key: a0f630f7-b184-4ab2-a282-117c25bc6e89
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SP-27015-01
• 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	00385640025607 [Primary]
GS1	10385640025604 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• EPP: Splint, Nasal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-09-10
• Device Publish Date: 2016-12-06

Devices Manufactured by SUMMIT MEDICAL, INC.

• 00385640086035 - INSTRUSAFE: 2025-04-01
• 00385640086042 - INSTRUSAFE: 2025-04-01
• 00385640086011 - INSTRUSAFE: 2025-03-31
• 00385640086028 - INSTRUSAFE: 2025-03-31
• 00385640085984 - INSTRUSAFE: 2025-03-28
• 00385640085991 - INSTRUSAFE: 2025-03-28
• 00385640086004 - INSTRUSAFE: 2025-03-28
• 00385640085953 - INSTRUSAFE: 2025-03-27