Elite

GUDID 00810633022030

BME ELITE H-SERIES DRILLING TEMPLATE KIT

Biomedical Enterprises, Inc.

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

• Primary Device ID: 00810633022030
• NIH Device Record Key: 3e8ca68e-f19b-4db0-bcf6-5c5267de484e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite
• Version Model Number: EL-DTH
• 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 Dimensions

• Lumen/Inner Diameter: 3 Millimeter
• Lumen/Inner Diameter: 3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810633022030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150125

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: 4
• Public Version Date: 2020-05-07
• Device Publish Date: 2017-02-15

On-Brand Devices [Elite]

• 00810633022030: BME ELITE H-SERIES DRILLING TEMPLATE KIT
• 00810633021972: BME ELITE Y-SERIES DRILLING TEMPLATE KIT
• 00810633021965: BME ELITE S-SERIES DRILLING TEMPLATE KIT
• 00810633021958: BME ELITE INSTRUMENT KIT
• 00810633021828: Drill Kit For BME ELITE System
• 00810633021811: ELITE 30x20x7mm, Y-Shaped Bridge, 4 Legs
• 00810633021804: ELITE 30x15x7mm, Y-Shaped Bridge, 4 Legs
• 00810633021798: ELITE 25x20x7mm, Y-Shaped Bridge, 4 Legs
• 00810633021781: ELITE 25x15x7mm, Y-Shaped Bridge, 4 Legs
• 00810633021774: ELITE 20x20x7mm, Y-Shaped Bridge, 3 Legs
• 00810633021767: ELITE 20x15x7mm, Y-Shaped Bridge, 3 Legs
• 00810633021750: ELITE 25x25x13mm, H-Shaped Bridge, 4 Legs
• 00810633021743: ELITE 25x20x13mm, H-Shaped Bridge, 4 Legs
• 00810633021736: ELITE 20x25x13mm, H-Shaped Bridge, 4 Legs
• 00810633021729: ELITE 20x20x13mm, H-Shaped Bridge, 4 Legs
• 00810633021712: ELITE 30x20x20mm, Straight Bridge, 4 Legs
• 00810633021705: ELITE 25x20x20mm, Straight Bridge, 4 Legs
• 00810633021699: ELITE 20x20x20mm, Straight Bridge, 2 Legs
• 00810633021682: ELITE 18x18x18mm, Straight Bridge, 2 Legs
• 00810633021675: ELITE 15x15x15mm, Straight Bridge, 2 Legs