PMT Drill Cutter 2103-219

GUDID 04251388958339

adeor Medical AG

Cranial bur, single-use

• Primary Device ID: 04251388958339
• NIH Device Record Key: 52608a2b-fea4-4517-bce5-d6393bf7cd0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PMT Drill Cutter
• Version Model Number: 2.2mmX254mm(10in.)
• Catalog Number: 2103-219
• 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	04251388958339 [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: 2025-05-05
• Device Publish Date: 2025-04-25

On-Brand Devices [PMT Drill Cutter]

• 04251388961025: 3.2mmX254mm(10in.)
• 04251388958339: 2.2mmX254mm(10in.)
• 04251388941119: 2.4mmX254mm(10in.)
• 04251388941102: 2.1mmx254mm(10in.)