HERNIATOME

GUDID 08033737113790

Percutaneous Discectomy Device

ADRIA SRL

Diskectomy system, percutaneous, automatic

• Primary Device ID: 08033737113790
• NIH Device Record Key: 7e6b46de-faf7-42c5-837c-fa475952313c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HERNIATOME
• Version Model Number: 5091715
• Company DUNS: 437941789
• Company Name: ADRIA SRL
• 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: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033737113790 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141557

FDA Product Code

• HRX: Arthroscope

Sterilization

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

[08033737113790]

Ethylene Oxide

[08033737113790]

Ethylene Oxide

[08033737113790]

Ethylene Oxide

[08033737113790]

Ethylene Oxide

[08033737113790]

Ethylene Oxide

[08033737113790]

Ethylene Oxide

[08033737113790]

Ethylene Oxide

[08033737113790]

Ethylene Oxide

[08033737113790]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-15
• Device Publish Date: 2025-04-07

On-Brand Devices [HERNIATOME]

• 08033737113844: Percutaneous Discectomy Device
• 08033737119983: Percutaneous Discectomy Device
• 08033737113790: Percutaneous Discectomy Device