HERNIATOME

GUDID 08033737113844

Percutaneous Discectomy Device

ADRIA SRL

Diskectomy system, percutaneous, automatic Diskectomy system, percutaneous, automatic Diskectomy system, percutaneous, automatic Diskectomy system, percutaneous, automatic Diskectomy system, percutaneous, automatic Diskectomy system, percutaneous, automatic Diskectomy system, percutaneous, automatic Diskectomy system, percutaneous, automatic Diskectomy system, percutaneous, automatic Diskectomy system, percutaneous, automatic Diskectomy system, percutaneous, automatic Diskectomy system, percutaneous, automatic Diskectomy system, percutaneous, automatic Diskectomy system, percutaneous, automatic Diskectomy system, percutaneous, automatic Diskectomy system, percutaneous, automatic Diskectomy system, percutaneous, automatic

• Primary Device ID: 08033737113844
• NIH Device Record Key: d27622ba-a936-4dc4-961f-a69894a37564
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HERNIATOME
• Version Model Number: 5091745
• 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: false
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033737113844 [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

[08033737113844]

Ethylene Oxide

[08033737113844]

Ethylene Oxide

[08033737113844]

Ethylene Oxide

[08033737113844]

Ethylene Oxide

[08033737113844]

Ethylene Oxide

[08033737113844]

Ethylene Oxide

[08033737113844]

Ethylene Oxide

[08033737113844]

Ethylene Oxide

[08033737113844]

Ethylene Oxide

[08033737113844]

Ethylene Oxide

[08033737113844]

Ethylene Oxide

[08033737113844]

Ethylene Oxide

[08033737113844]

Ethylene Oxide

[08033737113844]

Ethylene Oxide

[08033737113844]

Ethylene Oxide

[08033737113844]

Ethylene Oxide

[08033737113844]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-04
• Device Publish Date: 2023-09-26