OTOSILK™ Graft Dressing OT-4601

GUDID EBESOT46011

Size: 100 x 150 mm; Type: Nylon

BOSTON MEDICAL PRODUCTS, INC.

Wound-nonadherent dressing, permeable

• Primary Device ID: EBESOT46011
• NIH Device Record Key: c7b1450c-21e9-4434-ad60-c35ac2cb3a52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTOSILK™ Graft Dressing
• Version Model Number: OT-4601
• Catalog Number: OT-4601
• 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

• Length: 100 Millimeter
• Width: 150 Millimeter
• Length: 100 Millimeter
• Width: 150 Millimeter
• Length: 100 Millimeter
• Width: 150 Millimeter
• Length: 100 Millimeter
• Width: 150 Millimeter
• Length: 100 Millimeter
• Width: 150 Millimeter
• Length: 100 Millimeter
• Width: 150 Millimeter
• Length: 100 Millimeter
• Width: 150 Millimeter
• Length: 100 Millimeter
• Width: 150 Millimeter
• Length: 100 Millimeter
• Width: 150 Millimeter
• Length: 100 Millimeter
• Width: 150 Millimeter
• Length: 100 Millimeter
• Width: 150 Millimeter
• Length: 100 Millimeter
• Width: 150 Millimeter
• Length: 100 Millimeter
• Width: 150 Millimeter
• Length: 100 Millimeter
• Width: 150 Millimeter
• Length: 100 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	EBESOT46010 [Primary]
HIBCC	EBESOT46011 [Package]; Contains: EBESOT46010; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964534

FDA Product Code

• NAB: Gauze/Sponge,Nonresorbable For External Use

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 [OTOSILK™ Graft Dressing]

• EBESOT46011: Size: 100 x 150 mm; Type: Nylon
• 34063107102449: Size: 100 x 150 mm; Type: Nylon