HiCUT Burs OV55

GUDID 04251388939161

adeor Medical AG

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• Primary Device ID: 04251388939161
• NIH Device Record Key: 144e9a18-605e-4578-a39b-21beac0e2523
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HiCUT Burs
• Version Model Number: 5.5 mm oval
• Catalog Number: OV55
• 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	04251388939161 [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: 2021-06-18
• Device Publish Date: 2021-06-10

On-Brand Devices [HiCUT Burs]

• 04251388939185: 2.0 mm drill
• 04251388939109: 3.0 mm neuro Matchstick
• 04251388939062: 6.4 mm acorn
• 04251388939055: 6.5 mm barrel
• 04251388939048: 6.4 mm balltip
• 04251388939017: 3.2 mm balltip
• 04251388938928: 4.2 mm diamond ball coarse
• 04251388938904: 6.0 mm diamond ball coarse
• 04251388938898: 6.0 mm diamond ball standard
• 04251388938874: 4.2 mm diamond ball standard
• 04251388957639: 6.4 mm balltip TC
• 04251388957622: 4.8 mm balltip TC
• 04251388957615: 4.2 mm diamond ball extra coarse
• 04251388956793: 1.0 mm pin -30% blade length
• 04251388941171: 3.0 mm drill
• 04251388940600: 0.8 mm diamond ball coarse
• 04251388940006: 25.4 mm diamond disc
• 04251388939994: Metal cutter, 3.0 mm
• 04251388939598: Lindemann 1.65 x 20 mm
• 04251388939581: Lindemann 1.65 x 10 mm
• 04251388939178: 1.5 mm drill
• 04251388939161: 5.5 mm oval
• 04251388939154: 4.0 mm oval
• 04251388939147: 3.0 mm neuro diamond Matchstick
• 04251388939130: 2.2 mm neuro diamond Matchstick
• 04251388939123: 1.8 mm neuro diamond Matchstick
• 04251388939116: 1.0 mm neuro diamond Matchstick
• 04251388939093: 2.2 mm neuro Matchstick
• 04251388939086: 1.8 mm neuro Matchstick
• 04251388939079: 1.0 mm neuro Matchstick
• 04251388939031: 4.8 mm balltip
• 04251388939024: 4.0 mm balltip
• 04251388939000: 2.0 mm balltip
• 04251388938997: 1.5 mm balltip
• 04251388938980: 1.0 mm balltip
• 04251388938973: 1.0 mm pin
• 04251388938966: 1.0 mm diamond ball coarse
• 04251388938959: 1.5 mm diamond ball coarse
• 04251388938942: 2.1 mm diamond ball coarse
• 04251388938935: 3.3 mm diamond ball coarse
• 04251388938911: 5.0 mm diamond ball coarse
• 04251388938881: 5.0 mm diamond ball standard
• 04251388938867: 3.3 mm diamond ball standard
• 04251388938850: 2.1 mm diamond ball standard
• 04251388938843: 1.5 mm diamond ball standard
• 04251388938836: 1.0 mm diamond ball standard
• 04251388938829: 0.8 mm diamond ball standard
• 04251388938812: Craniotome Cutter, spiral blade, large
• 04251388938805: Craniotome Cutter, large
• 04251388938799: Craniotome Cutter, spiral blade, medium