Speed Hand and Wrist

GUDID 00810633021835

Drill Kit for Speed Hand and Wrist 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: 00810633021835
• NIH Device Record Key: 3b755ff5-a491-4d4c-aeb0-0122cfd46696
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Speed Hand and Wrist
• Version Model Number: DK-200HW
• 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: 210-881-0043
• Email: gupton@bme-tx.com
• Phone: 210-881-0043
• Email: gupton@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 Millimeter
• Outer Diameter: 2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810633021835 [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

Devices Manufactured by Biomedical Enterprises, Inc.

• 00810633022047 - N/A: 2020-05-07 DEPUY SYNTHES HAMMERTOE CCI STD KIT W/1.25 K-WIRE/ STERILE
• 00810633022054 - N/A: 2020-05-07 DEPUY SYNTHES HAMMERTOE CCI LARGE KIT W/1.60 K-WIRE/ STERILE
• 00810633022085 - N/A: 2020-05-07 Speed 2.0mm Instrument Kit Comprehensive
• 00810633022092 - N/A: 2020-05-07 Speed 2.65mm Instrument Kit Comprehensive
• 00810633020005 - HammerLock: 2020-05-07 Medium, 19mm length Nitinol Intramedullary Implant
• 00810633020012 - HammerLock: 2020-05-07 Hammerlock implant for DIP
• 00810633020029 - HammerLock: 2020-05-07 Hammerlock X-Type Large
• 00810633020036 - HammerLock: 2020-05-07 Hammerlock Angled X-Type Large