HiCUT Micro saw VMN-O-8-S

GUDID 04251388941812

adeor Medical AG

Surgical saw blade, oscillating, single-use

• Primary Device ID: 04251388941812
• NIH Device Record Key: 504e71aa-7c86-4862-aae9-ecc00fc49b1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HiCUT Micro saw
• Version Model Number: oscillating 8 mm
• Catalog Number: VMN-O-8-S
• Company DUNS: 341188943
• Company Name: adeor Medical AG
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251388941812 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130755

FDA Product Code

• HBE: Drills, Burrs, Trephines & Accessories (Simple, Powered)

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: 2021-06-21
• Device Publish Date: 2021-06-11

On-Brand Devices [HiCUT Micro saw]

• 04251388941874: sagittal 10 mm
• 04251388941867: sagittal 6 mm
• 04251388941850: reciprocating 30 mm
• 04251388941843: reciprocating 20 mm
• 04251388941836: reciprocating 15 mm
• 04251388941829: oscillating 15 mm
• 04251388941812: oscillating 8 mm