Bivalve Nasal Splint, Standard

Basic Information

• Brand Name: Bivalve Nasal Splint, Standard
• Primary DI: 14063107102308
• Version / Model: 60-302
• Catalog Number: 60-302
• Company Name: Boston Medical Products, Inc.
• Labeler DUNS: 131855157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-29
• Public Version: 1
• Public Version Date: 2022-10-07
• Public Version Status: New
• Public Device Record Key: 6d03ab9e-02dc-4ce5-80bb-254aff979e79

Device Description

Size: 0.50 x 27 x 42 mm

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	874.4780	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31919	Intranasal splint, non-biodegradable	A non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	34063107102302	GS1	Carton	10	In Commercial Distribution
Primary	14063107102308	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K972096	000

Device Sizes

Type	Value	Unit	Text
Height	42	Millimeter
Length	27	Millimeter
Width	0.50	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry