Meridian Perforator PER 11-14-SP

GUDID EADEPER1114SP1

adeor Medical AG

Automatic cranial perforator, single-use

• Primary Device ID: EADEPER1114SP1
• NIH Device Record Key: 42f65f51-8818-4925-beb9-4c13830e168f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Meridian Perforator
• Version Model Number: alpha
• Catalog Number: PER 11-14-SP
• 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
HIBCC	EADEPER1114SP1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121253

FDA Product Code

• HBF: Drills, Burrs, Trephines & Accessories (Compound, Powered)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2017-02-11

On-Brand Devices [Meridian Perforator]

• EADEPERC811S1: Classic
• EADEPERC69S1: Classic
• EADEPERC1114S1: Classic
• EADEPER711SP1: alpha
• EADEPER711S1: alpha
• EADEPER1114SP1: alpha
• EADEPER1114SG1: alpha
• EADEPER1114S1: alpha