Bivalve Nasal Splint, Standard 60-301

GUDID 34063107102296

Size: 0.25 x 27 x 42 mm

Boston Medical Products, Inc.

Intranasal splint, non-biodegradable

• Primary Device ID: 34063107102296
• NIH Device Record Key: e600c002-56fd-45f4-94da-502aee5fa9a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bivalve Nasal Splint, Standard
• Version Model Number: 60-301
• Catalog Number: 60-301
• Company DUNS: 131855157
• Company Name: Boston Medical Products, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com
• Phone: 1-800-433-2674
• Email: info@bosmed.com

Device Dimensions

• Width: 0.25 Millimeter
• Length: 27 Millimeter
• Height: 42 Millimeter
• Width: 0.25 Millimeter
• Length: 27 Millimeter
• Height: 42 Millimeter
• Width: 0.25 Millimeter
• Length: 27 Millimeter
• Height: 42 Millimeter
• Width: 0.25 Millimeter
• Length: 27 Millimeter
• Height: 42 Millimeter
• Width: 0.25 Millimeter
• Length: 27 Millimeter
• Height: 42 Millimeter
• Width: 0.25 Millimeter
• Length: 27 Millimeter
• Height: 42 Millimeter
• Width: 0.25 Millimeter
• Length: 27 Millimeter
• Height: 42 Millimeter
• Width: 0.25 Millimeter
• Length: 27 Millimeter
• Height: 42 Millimeter
• Width: 0.25 Millimeter
• Length: 27 Millimeter
• Height: 42 Millimeter
• Width: 0.25 Millimeter
• Length: 27 Millimeter
• Height: 42 Millimeter
• Width: 0.25 Millimeter
• Length: 27 Millimeter
• Height: 42 Millimeter
• Width: 0.25 Millimeter
• Length: 27 Millimeter
• Height: 42 Millimeter
• Width: 0.25 Millimeter
• Length: 27 Millimeter
• Height: 42 Millimeter
• Width: 0.25 Millimeter
• Length: 27 Millimeter
• Height: 42 Millimeter
• Width: 0.25 Millimeter
• Length: 27 Millimeter
• Height: 42 Millimeter
• Width: 0.25 Millimeter
• Length: 27 Millimeter
• Height: 42 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	14063107102292 [Primary]
GS1	34063107102296 [Package]; Contains: 14063107102292; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972096

FDA Product Code

• LYA: Splint, Intranasal Septal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-07
• Device Publish Date: 2022-09-29

On-Brand Devices [Bivalve Nasal Splint, Standard]

• EBES603020: Size: 0.50 x 27 x 42 mm
• EBES603010: Size: 0.25 x 27 x 42 mm
• 34063107102302: Size: 0.50 x 27 x 42 mm
• 34063107102296: Size: 0.25 x 27 x 42 mm