Acra-Cut Reusable Cranial Perforator 200-152 DGR-II

GUDID 00810607000484

Acra-Cut Reusable Cranial Perforator

ACRA-CUT INC

Cranial trephine, reusable Cranial trephine, reusable

• Primary Device ID: 00810607000484
• NIH Device Record Key: 234c1070-f899-4d79-a373-c8b09bcd8a01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acra-Cut Reusable Cranial Perforator
• Version Model Number: 200-152 DGR-II
• Catalog Number: 200-152 DGR-II
• Company DUNS: 612611459
• Company Name: ACRA-CUT INC
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9782632210
• Email: info@acracut.com
• Phone: 9782632210
• Email: info@acracut.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810607000484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K833266

FDA Product Code

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

Sterilization

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

[00810607000484]

Moist Heat or Steam Sterilization

[00810607000484]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-01

On-Brand Devices [Acra-Cut Reusable Cranial Perforator]

• 00810607000491: Acra-Cut Reusable Cranial Perforator
• 00810607000484: Acra-Cut Reusable Cranial Perforator
• 00810607000477: Acra-Cut Reusable Cranial Perforator
• 00810607000460: Acra-Cut Reusable Cranial Perforator