CRW frame adaptor ROSAS00321

GUDID 03760244030962

CRW FRAME ADAPTOR instrument Rosa One 3.1 (brain application) Mechanical adaptor to connect the support arm to the CRW stereotactic frame. Supplied with 8 mm hexagonal key

MEDTECH

Multi-purpose stereotactic surgery system

• Primary Device ID: 03760244030962
• NIH Device Record Key: 6e8efd9a-96ee-426c-befd-ff2c8abe0a6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRW frame adaptor
• Version Model Number: 174010
• Catalog Number: ROSAS00321
• Company DUNS: 264502977
• Company Name: MEDTECH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760244030962 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200511

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-30
• Device Publish Date: 2020-11-20

On-Brand Devices [CRW frame adaptor]

• 03760244031204: CRW FRAME ADAPTOR instrument Rosa 3.0 instrument Rosa 3.1 Mechanical adaptor to connect the supp
• 03760244030962: CRW FRAME ADAPTOR instrument Rosa One 3.1 (brain application) Mechanical adaptor to connect the