Black Diamond Rattlesnake

GUDID B014BD5535

EMINENT SPINE LLC

External spinal fixation system

• Primary Device ID: B014BD5535
• NIH Device Record Key: a5a8f129-e4c4-461e-969c-dbfe0c9ce8b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Black Diamond Rattlesnake
• Version Model Number: BD5535
• Company DUNS: 022576742
• Company Name: EMINENT SPINE LLC
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B014BD5535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133194

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B014BD5535]

Moist Heat or Steam Sterilization

[B014BD5535]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-29
• Device Publish Date: 2017-02-08

On-Brand Devices [Black Diamond Rattlesnake]

• B014BD5555: BD5555
• B014BD5550: BD5550
• B014BD5545: BD5545
• B014BD5540: BD5540
• B014BD5535: BD5535
• B014BD5530: BD5530
• B014BD5525: BD5525
• B014BD133: BD133
• B014BD131: BD131
• B014BD129: BD129
• B014BD127: BD127
• B014BD125: BD125
• B014BD123: BD123
• B014BD121: BD121