BOSS

GUDID 00810633020746

BOSS 11X8X8 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: 00810633020746
• NIH Device Record Key: 89a42764-41cf-4bf9-b90d-410f907d5851
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOSS
• Version Model Number: 440-9111
• 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: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Width: 11 Millimeter
• Length: 8 Millimeter
• Width: 11 Millimeter
• Length: 8 Millimeter
• Width: 11 Millimeter
• Length: 8 Millimeter
• Width: 11 Millimeter
• Length: 8 Millimeter
• Width: 11 Millimeter
• Length: 8 Millimeter
• Width: 11 Millimeter
• Length: 8 Millimeter
• Width: 11 Millimeter
• Length: 8 Millimeter
• Width: 11 Millimeter
• Length: 8 Millimeter
• Width: 11 Millimeter
• Length: 8 Millimeter
• Width: 11 Millimeter
• Length: 8 Millimeter
• Width: 11 Millimeter
• Length: 8 Millimeter
• Width: 11 Millimeter
• Length: 8 Millimeter
• Width: 11 Millimeter
• Length: 8 Millimeter
• Width: 11 Millimeter
• Length: 8 Millimeter
• Width: 11 Millimeter
• Length: 8 Millimeter
• Width: 11 Millimeter
• Length: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810633020746 [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 [BOSS]

• 00810633021026: BOSS 18X18X15 W2
• 00810633020906: BOSS 20X30X30 W2X3
• 00810633020890: BOSS 25X22X22 BW2X3
• 00810633020883: BOSS 20X20X20 W2X3
• 00810633020821: BOSS 15X18X18 W2
• 00810633020814: BOSS 20X20X20 W2
• 00810633020807: BOSS 15X12X12 W2
• 00810633020777: BOSS 11X10X10 W1.5
• 00810633020760: BOSS 15X12X12 W1.5
• 00810633020753: BOSS 13X10X10 W1.5
• 00810633020746: BOSS 11X8X8 W1.5
• 00810633020739: BOSS 9X7X7 W1.2