N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00385640045841
• Version / Model: AQ-9x12-21
• Company Name: Summit Medical, Inc.
• Labeler DUNS: 965484699
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-27
• Public Version: 8
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: bdc29fc9-c549-41d2-9224-106a7fba4fec

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EPP	Splint, Nasal	Ear, Nose, Throat	874.5800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35411	External nasal splint	A rigid or semi-rigid device intended to be applied externally to the nose for the immobilization of nasal bones and cartilage, typically after a fracture or surgery. It functions as a truss-like support on the outside of the nose. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00385640045841	GS1