Intracept

GUDID 00852454006226

Intracept Access Instruments

RELIEVANT MEDSYSTEMS, INC.

Neurosurgical procedure kit, non-medicated, single-use

• Primary Device ID: 00852454006226
• NIH Device Record Key: 823a12c4-cfb3-42df-ae89-fc758065e2c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intracept
• Version Model Number: RLV 0055
• Company DUNS: 808344183
• Company Name: RELIEVANT MEDSYSTEMS, 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: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852454006226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222281

FDA Product Code

• GXI: Probe, Radiofrequency Lesion

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-28
• Device Publish Date: 2023-04-20

On-Brand Devices [Intracept]

• 00852454006196: Contains: (1) Intracept RF Probe and (1) Intracept Access Instruments
• 10852454006186: Intracept Access Instruments
• 00852454006158: Contains: (1) Intracept Flexible Bi-Polar RF Probe and (1) Intracept Access Instruments - Bevel
• 00852454006141: Contains: (1) Intracept Flexible Bi-Polar RF Probe and (1) Intracept Access Instruments - Trocar
• 10852454006124: Intracept Flexible Bi-Polar RF Probe
• 10852454006087: Intracept Access Instruments - Bevel
• 10852454006032: Intracept Access Instruments - Additional Level
• 10852454006025: Intracept Access Instruments - Trocar
• 10852454006001: Intracept RF Probe
• 00852454006257: Intracept Access Instruments - Additional VB
• 00852454006240: Intracept Drill
• 00852454006233: Intracept Procedure Kit
• 00852454006226: Intracept Access Instruments
• 00852454006301: Intracept Access Instruments 2 VB