OSSARC

GUDID 00810633021019

OSSARC 11X15X12-18 W1.5

Biomedical Enterprises, Inc.

Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable

• Primary Device ID: 00810633021019
• NIH Device Record Key: d73f75fc-e00a-462e-8393-7593afd68947
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSARC
• Version Model Number: 540-5211
• Company DUNS: 792619009
• Company Name: Biomedical Enterprises, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 210-881-0064
• Email: aknight@bme-tx.com
• Phone: 210-881-0064
• Email: aknight@bme-tx.com
• Phone: 210-881-0064
• Email: aknight@bme-tx.com
• Phone: 210-881-0064
• Email: aknight@bme-tx.com
• Phone: 210-881-0064
• Email: aknight@bme-tx.com
• Phone: 210-881-0064
• Email: aknight@bme-tx.com
• Phone: 210-881-0064
• Email: aknight@bme-tx.com
• Phone: 210-881-0064
• Email: aknight@bme-tx.com
• Phone: 210-881-0064
• Email: aknight@bme-tx.com
• Phone: 210-881-0064
• Email: aknight@bme-tx.com
• Phone: 210-881-0064
• Email: aknight@bme-tx.com
• Phone: 210-881-0064
• Email: aknight@bme-tx.com
• Phone: 210-881-0064
• Email: aknight@bme-tx.com
• Phone: 210-881-0064
• Email: aknight@bme-tx.com
• Phone: 210-881-0064
• Email: aknight@bme-tx.com
• Phone: 210-881-0064
• Email: aknight@bme-tx.com
• Phone: 210-881-0064
• Email: aknight@bme-tx.com
• Phone: 210-881-0064
• Email: aknight@bme-tx.com

Device Dimensions

• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Length: 15 Millimeter
• Angle: 18 degree
• Width: 11 Millimeter
• Length: 15 Millimeter
• Angle: 18 degree
• Width: 11 Millimeter
• Length: 15 Millimeter
• Angle: 18 degree
• Width: 11 Millimeter
• Length: 15 Millimeter
• Angle: 18 degree
• Width: 11 Millimeter
• Length: 15 Millimeter
• Angle: 18 degree
• Width: 11 Millimeter
• Length: 15 Millimeter
• Angle: 18 degree
• Width: 11 Millimeter
• Length: 15 Millimeter
• Angle: 18 degree
• Width: 11 Millimeter
• Length: 15 Millimeter
• Angle: 18 degree
• Width: 11 Millimeter
• Length: 15 Millimeter
• Angle: 18 degree
• Width: 11 Millimeter
• Length: 15 Millimeter
• Angle: 18 degree
• Width: 11 Millimeter
• Length: 15 Millimeter
• Angle: 18 degree
• Width: 11 Millimeter
• Length: 15 Millimeter
• Angle: 18 degree
• Width: 11 Millimeter
• Length: 15 Millimeter
• Angle: 18 degree
• Width: 11 Millimeter
• Length: 15 Millimeter
• Angle: 18 degree
• Width: 11 Millimeter
• Length: 15 Millimeter
• Angle: 18 degree
• Width: 11 Millimeter
• Length: 15 Millimeter
• Angle: 18 degree
• Width: 11 Millimeter
• Length: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810633021019 [Primary]

FDA Product Code

• JDR: Staple, Fixation, Bone

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: 2020-05-07
• Device Publish Date: 2015-10-24

On-Brand Devices [OSSARC]

• 00810633021439: OSSARC 11x15x13 15BW1.5
• 00810633021019: OSSARC 11X15X12-18 W1.5
• 00810633021002: OSSARC 11X15X12 W1.5