HammerLock2

GUDID 00810633021507

Drill Kit for BME HammerLock2 System

Biomedical Enterprises, Inc.

Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00810633021507
• NIH Device Record Key: 0d2ba4ef-458f-43be-be56-6fba679efb48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HammerLock2
• Version Model Number: DK-H2
• 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: 1-800-255-2500
• Email: xx@xx.xx
• Phone: 1-800-255-2500
• Email: xx@xx.xx
• Phone: 1-800-255-2500
• Email: xx@xx.xx
• Phone: 1-800-255-2500
• Email: xx@xx.xx
• Phone: 1-800-255-2500
• Email: xx@xx.xx
• Phone: 1-800-255-2500
• Email: xx@xx.xx
• Phone: 1-800-255-2500
• Email: xx@xx.xx
• Phone: 1-800-255-2500
• Email: xx@xx.xx
• Phone: 1-800-255-2500
• Email: xx@xx.xx
• Phone: 1-800-255-2500
• Email: xx@xx.xx
• Phone: 1-800-255-2500
• Email: xx@xx.xx
• Phone: 1-800-255-2500
• Email: xx@xx.xx
• Phone: 1-800-255-2500
• Email: xx@xx.xx
• Phone: 1-800-255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Dimensions

• Outer Diameter: 2.15 Millimeter
• Outer Diameter: 2.15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810633021507 [Primary]

FDA Product Code

• KDD: Kit, Surgical Instrument, Disposable

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 [HammerLock2]

• 00810633021507: Drill Kit for BME HammerLock2 System
• 00810633021491: HammerLock2 12mm Proximal – 5mm Distal Implant, Angled
• 00810633021484: HammerLock2 12mm Proximal – 5mm Distal Implant
• 00810633021477: HammerLock2 15mm Proximal – 5mm Distal Implant, Angled
• 00810633021460: HammerLock2 15mm Proximal – 5mm Distal Implant
• 00810633021453: HammerLock2 15mm Proximal – 7mm Distal Implant, Angled
• 00810633021446: Hammerlock X-Type LargeHammerLock2 15mm Proximal – 7mm Distal Implant