Mectascope

GUDID 07630040733526

MectaScope - Rotating Sheath,Double stopcock, WL=15cm

Medacta International SA

Rigid endoscope telescope

• Primary Device ID: 07630040733526
• NIH Device Record Key: 7be86d95-cc22-4210-bd62-6c43e24015a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mectascope
• Version Model Number: 05.17.10.0005
• Company DUNS: 488227125
• Company Name: Medacta International SA
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
GS1	07630040733526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200067

FDA Product Code

• HRX: Arthroscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-14
• Device Publish Date: 2020-10-06

On-Brand Devices [Mectascope]

• 07630040733540: MectaScope - Blunt Obturator – W/o handle
• 07630040733533: MectaScope - Obturator W/handle Cannulated Ø1.6mm
• 07630040733526: MectaScope - Rotating Sheath,Double stopcock, WL=15cm
• 07630040733519: MectaScope - Scope 70°, Ø4 L=18cm Autoclavable HD
• 07630040733502: MectaScope - Scope 30°, Ø4 L=18cm Autoclavable HD