OTOSILK™ Graft Dressing OT-4601

GUDID 34063107102449

Size: 100 x 150 mm; Type: Nylon

Boston Medical Products, Inc.

Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial Wound-nonadherent dressing, permeable, non-antimicrobial

• Primary Device ID: 34063107102449
• NIH Device Record Key: b89c3a96-f943-4c2c-9408-bc084d852d25
• 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

• 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
• Width: 150 Millimeter
• Length: 100 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	14063107102445 [Primary]
GS1	34063107102449 [Package]; Contains: 14063107102445; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-08
• Device Publish Date: 2022-08-31

On-Brand Devices [OTOSILK™ Graft Dressing]

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