Speed

GUDID 00810633022016

SPEED 13X12X12mm implant

Biomedical Enterprises, Inc.

Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile 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: 00810633022016
• NIH Device Record Key: 06b3b3e2-00a3-44ac-8f10-ae9a0e278a03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Speed
• Version Model Number: SE-1312
• Company DUNS: 792619009
• Company Name: Biomedical Enterprises, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
• 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
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Dimensions

• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *May be stored at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *May be stored at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *May be stored at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *May be stored at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *May be stored at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *May be stored at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *May be stored at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *May be stored at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *May be stored at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *May be stored at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *May be stored at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *May be stored at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *May be stored at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *May be stored at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *May be stored at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *May be stored at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810633022016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142292

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: 2016-05-06

On-Brand Devices [Speed]

• 00810633022023: SPEED 15X10X10mm implant
• 00810633022016: SPEED 13X12X12mm implant
• 00810633022009: SPEED 13X8X8mm implant
• 00810633021996: SPEED 11X8X8mm implant
• 00810633021583: Speed ARC Sizing Guide
• 00810633021354: Sterile 3.2MM Drill Bit
• 00810633021347: Sterile 1.6MM Drill Bit
• 00810633020630: Drill Bit Kit used with SHIFT
• 00810633020418: Sterile 2.0mm Drill Bit Kit without drill Stop for Continuous Compression
• 00810633020401: Sterile 2.65mm Drill Bit Kit without Drill Stop for Continuous Compression
• 00810633020364: Sterile 2.64mm Drill Bit
• 00810633020357: Sterile 3.0mm Drill Bit
• 00810633020340: Sterile 1.8mm Drill Bit
• 00810633020333: Sterile 1.4mm Drill Bit
• 00810633020302: Continuous Compression Implant Drill Kit w/S-265QD
• 00810633020296: Continuous Compression Implant Drill Kit w/S-200QD
• 00810633020289: Lite SPEED 11X15X13mm nitinol implant
• 00810633020272: Lite SPEED 11X10X10mm nitinol implant
• 00810633020265: Lite SPEED 09X10X10mm nitinol implant
• 00810633020258: Lite SPEED 09X07X07mm nitinol implant
• 00810633020241: Implant Sizing Guide
• 00810633020234: SPEED 25X20X20mm implant
• 00810633020227: SPEED 20X20X20mm implant
• 00810633020210: SPEED 20X15X15mm implant
• 00810633020203: SPEED 18X18X15mm implant
• 00810633020197: SPEED 18X18X18mm implant
• 00810633020180: SPEED 18X15X15mm implant
• 00810633020173: SPEED 15X15X15mm implant
• 00810633020166: SPEED 15X12X12mm implant
• 00810633020159: SPEED 13X15X13mm implant
• 00810633020142: SPEED 13X10X10mm implant
• 00810633020135: SPEED 11X15X13mm implant
• 00810633020128: SPEED 11X10X10mm implant
• 00810633020111: SPEED 9X10X10mm implant
• 00810633020104: SPEED 9X7X7mm implant