LEKSELL FRAME ADAPTOR ROSAS00348

GUDID 03760244031396

LEKSELL FRAME ADAPTOR instrument Rosa 3.0 instrument Rosa 3.1 Mechanical adaptor to connect the support arm to the leksell stereotactic frame, supplied with 8 mm hexagonal key

MEDTECH

Multi-purpose stereotactic surgery system

• Primary Device ID: 03760244031396
• NIH Device Record Key: 2a71ff08-1d48-4c23-9bb2-7e1361f34bc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEKSELL FRAME ADAPTOR
• Version Model Number: ROSA3-176C
• Catalog Number: ROSAS00348
• Company DUNS: 264502977
• Company Name: MEDTECH
• 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: true
• 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	03760244031396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151359

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-03
• Device Publish Date: 2016-10-09

On-Brand Devices [LEKSELL FRAME ADAPTOR]

• 03760244031396: LEKSELL FRAME ADAPTOR instrument Rosa 3.0 instrument Rosa 3.1 Mechanical adaptor to connect the
• 03760244033598: "LEKSELL FRAME ADAPTOR instrument Rosa One 3.1 (brain application) Mechanical adaptor to connect
• 03760244032126: "LEKSELL FRAME ADAPTOR instrument Rosa One 3.1 (brain application) Mechanical adaptor to connect