Cottonmouth

GUDID B014A3012

EMINENT SPINE LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: B014A3012
• NIH Device Record Key: 4be6c356-d776-4650-b3b4-e5a8a467c7ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cottonmouth
• Version Model Number: A3012
• 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	B014A3012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090064

FDA Product Code

• MQP: Spinal Vertebral Body Replacement Device

Sterilization

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

[B014A3012]

Moist Heat or Steam Sterilization

[B014A3012]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-02-08

On-Brand Devices [Cottonmouth]

• B014A6120: A6120
• B014A6118: A6118
• B014A6116: A6116
• B014A6114: A6114
• B014A6112: A6112
• B014A6110: A6110
• B014A6020: A6020
• B014A6018: A6018
• B014A6016: A6016
• B014A6014: A6014
• B014A6012: A6012
• B014A6010: A6010
• B014A5120: A5120
• B014A5118: A5118
• B014A5116: A5116
• B014A5114: A5114
• B014A5112: A5112
• B014A5110: A5110
• B014A5020: A5020
• B014A5018: A5018
• B014A5016: A5016
• B014A5014: A5014
• B014A5012: A5012
• B014A5010: A5010
• B014A4120: A4120
• B014A4118: A4118
• B014A4116: A4116
• B014A4114: A4114
• B014A4112: A4112
• B014A4110: A4110
• B014A4020: A4020
• B014A4018: A4018
• B014A4016: A4016
• B014A4014: A4014
• B014A4012: A4012
• B014A4010: A4010
• B014A3120: A3120
• B014A3118: A3118
• B014A3116: A3116
• B014A3114: A3114
• B014A3112: A3112
• B014A3110: A3110
• B014A3020: A3020
• B014A3018: A3018
• B014A3016: A3016
• B014A3014: A3014
• B014A3012: A3012
• B014A3010: A3010
• B014A2120: A2120
• B014A2118: A2118