CRW™

GUDID M248CRWBP1

CRW™ BiopsyPlus Kit - Single Use

INTEGRA LIFESCIENCES CORPORATION

Brain biopsy procedure kit

• Primary Device ID: M248CRWBP1
• NIH Device Record Key: cdb77ab8-fb1d-4082-b9fa-7ae2f5d3f7d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRW™
• Version Model Number: CRWBP
• Company DUNS: 963856096
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780252603 [Primary]
HIBCC	M248CRWBP1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032054

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-09-16
• Device Publish Date: 2016-07-26

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