Rutter Stent 840013

GUDID EBES8400130

Size: 13 mm; Type: Radiopaque

BOSTON MEDICAL PRODUCTS, INC.

Polymeric laryngeal stent

• Primary Device ID: EBES8400130
• NIH Device Record Key: ae8d78c7-7645-4845-a95f-dc20bb8482d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rutter Stent
• Version Model Number: 840013
• Catalog Number: 840013
• 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: 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: 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

• Outer Diameter: 13 Millimeter
• Length: 133 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 133 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 133 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 133 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 133 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 133 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 133 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 133 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 133 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 133 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 133 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 133 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 133 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 133 Millimeter
• Outer Diameter: 13 Millimeter

Operating and Storage Conditions

• 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
HIBCC	EBES8400130 [Primary]
HIBCC	EBES8400131 [Package]; Package: Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091135

FDA Product Code

• FWN: Prosthesis, Larynx (Stents And Keels)

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: 2018-07-06
• Device Publish Date: 2015-09-20

On-Brand Devices [Rutter Stent]

• EBES8400150: Size: 15 mm; Type: Radiopaque
• EBES8400140: Size: 14 mm; Type: Radiopaque
• EBES8400130: Size: 13 mm; Type: Radiopaque
• EBES8400120: Size: 12 mm; Type: Radiopaque
• EBES8400110: Size: 11 mm; Type: Radiopaque
• EBES8400100: Size: 10 mm; Type: Radiopaque
• EBES8400090: Size: 9 mm; Type: Radiopaque
• EBES8400080: Size: 8 mm; Type: Radiopaque
• EBES8400070: Size: 7 mm; Type: Radiopaque
• EBES8400060: Size: 6 mm; Type: Radiopaque
• 14063107101738: Size: 15 mm; Type: Radiopaque
• 14063107101721: Size: 14 mm; Type: Radiopaque
• 14063107101714: Size: 13 mm; Type: Radiopaque
• 14063107101707: Size: 12 mm; Type: Radiopaque
• 14063107101691: Size: 11 mm; Type: Radiopaque
• 14063107101684: Size: 10 mm; Type: Radiopaque
• 14063107101677: Size: 9 mm; Type: Radiopaque
• 14063107101660: Size: 8 mm; Type: Radiopaque
• 14063107101653: Size: 7 mm; Type: Radiopaque
• 14063107101646: Size: 6 mm; Type: Radiopaque