Wire Pass Drill 800-330 Single

GUDID 00810607000422

Wire Pass Drill 800-330 Single

ACRA-CUT INC

Cranial trephine, single-use Cranial trephine, single-use

• Primary Device ID: 00810607000422
• NIH Device Record Key: 803ab340-3620-4df3-b35e-0c43146df29c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wire Pass Drill
• Version Model Number: 800-330 Single
• Catalog Number: 800-330 Single
• 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: 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: 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	00810607000422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911812

FDA Product Code

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

Sterilization

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

[00810607000422]

Radiation Sterilization

[00810607000422]

Radiation 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: 2017-05-01

On-Brand Devices [Wire Pass Drill]

• 00810607000439: Wire Pass Drill 800-330 Package of 5
• 00810607000422: Wire Pass Drill 800-330 Single