Speed Shift

GUDID 00810633020517

Shift Implant Sizer (Offset sizing tool)

Biomedical Enterprises, Inc.

Surgical implant template, single-use Surgical implant template, single-use

• Primary Device ID: 00810633020517
• NIH Device Record Key: 0ee7119f-06ac-4028-bf22-f16d70ec5ef7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Speed Shift
• Version Model Number: OT-1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810633020517 [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: 4
• Public Version Date: 2020-05-07
• Device Publish Date: 2015-10-24

On-Brand Devices [Speed Shift]

• 00810633020517: Shift Implant Sizer (Offset sizing tool)
• 00810633020500: Speed Shift 20x20x20 Offset 12mm Implant
• 00810633020494: Speed Shift 20x20x20 Offset 10mm Implant
• 00810633020487: Speed Shift 20x20x20 Offset 08mm Implant
• 00810633020470: Speed Shift 20x20x20 Offset 06mm Implant
• 00810633020463: Speed Shift 20x20x20 Offset 04mm Implant
• 00810633020456: Speed Shift 20x20x20 Offset 02mm Implant
• 00810633020449: Speed Shift 15x20x20 Offset 10mm Implant
• 00810633020432: Speed Shift 15x20x20 Offset 8mm Implant
• 00810633020425: Speed Shift 15x20x20 Offset 6mm Implant