SP-78100

GUDID 00385640000000

SUMMIT MEDICAL, INC.

Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable Intranasal splint, non-biodegradable

• Primary Device ID: 00385640000000
• NIH Device Record Key: 2b5696f1-680c-4089-ab35-c1a36420957f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SP-78100
• Catalog Number: SP-78100
• Company DUNS: 965484699
• Company Name: SUMMIT MEDICAL, INC.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com
• Phone: 8882292875
• Email: customerservice@summitmedicalusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385640000000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982667

FDA Product Code

• LFB: Button, Nasal Septal

Sterilization

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

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

[00385640000000]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-10
• Device Publish Date: 2016-06-06

Devices Manufactured by SUMMIT MEDICAL, INC.

• 00385640080798 - INSTRUSAFE: 2024-04-25
• 00385640080804 - INSTRUSAFE: 2024-04-25
• 00385640080774 - INSTRUSAFE: 2024-04-24
• 00385640080781 - INSTRUSAFE: 2024-04-24
• 00385640017954 - INSTRUSAFE: 2024-04-22
• 00385640080712 - INSTRUSAFE: 2024-04-19
• 00385640080729 - INSTRUSAFE: 2024-04-19
• 00385640080736 - INSTRUSAFE: 2024-04-19