MagPro Accessories 9016B0491

GUDID 05713484031105

Tonica Elektronik A/S

Magnetic neural stimulation system

• Primary Device ID: 05713484031105
• NIH Device Record Key: 5fa34fd9-9e5d-4bd1-a35d-c0999304a8b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MagPro Accessories
• Version Model Number: Small Neck Rest for Treatment Chair
• Catalog Number: 9016B0491
• Company DUNS: 566622973
• Company Name: Tonica Elektronik A/S
• 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: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713484031105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150641

FDA Product Code

• OBP: Transcranial Magnetic Stimulator

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: 2023-02-20
• Device Publish Date: 2023-02-10

On-Brand Devices [MagPro Accessories]

• 05713484031235: Include Extra Coil Clamps with ø38mm and 29mm (9016B0811, 9016B0841, 9016B0861).
• 05713484031068: Markning Acc- Adjustable for DLPFC Left 5cm
• 05713484030948: pacekd af 10pcs of each size XS-S-M-L-XL
• 05713484030924: Treatment Chair
• 05713484030573: Isolation Transformer 120 V
• 05713484030290: Acc for MagPro R20
• 05713484030160: Acc. for G3 Trolley
• 05713484030061: Flex Arm-Short
• 05713484030054: Mounting kit included
• 05713484031341: Vacum Pillow 70 cm
• 05713484031310: Flow Arm coil adapter kit for A/P coils, ø38-1pcs. Approved with Flow Arm (9016B0801).
• 05713484031303: Flow Am coil adapter kit, ø29-2pcs. Approved with Flow Arm (9016B0801).
• 05713484031242: Flow Arm Coil adapter kit, ø38-2pcs. Approved with Flow Arm (9016B0801).
• 05713484031211: Markning acc. MCF/B-70 Clips-on, Left 5.5 cm
• 05713484031129: Pillow case for Vacum Pillow.
• 05713484030979: Markning acc., B65 Clips-on- Left 5.5cm
• 05713484030726: cable splitter for external triggering af a MagPro slave device as well as an external device. A
• 05713484030702: MagPro accessories, approved with MagPro R30 in K061645.
• 05713484030696: Cable accessories for MagPro, approved with MagPro R30 in K061645.
• 05713484030528: Approved with MEP Monitor, K061645
• 05713484030405: Approved with trolley. Extra shelf for MagPro trolley.
• 05713484030337: Markning acc studies, Left 5.5cm
• 05713484030313: Approved with Treatment Chair (9016B0081). Cloth cover for treatment chair.
• 05713484030306: Approved with Treatment Chair (9016B0081). Plastic cover for the foot rest of the treatment chai
• 05713484030238: Trolle for MagPro R20
• 05713484030221: Approved with Flex Arm, K150641.
• 05713484030146: Pillow Case 55cm
• 05713484030078: Markning Acc. (C-B60 Clips on)
• 05713484030047: External cooling system for Cool Coils
• 05713484030016: Trolley for MagPro X/R
• 05713484031105: Small Neck Rest for Treatment Chair
• 05713484031051: Markning accessories for Deperssion Treatment (MCF-/ Cool-B70 Clips-on), Right 5.5cm
• 05713484030955: Universal Holder
• 05713484030283: Trolley for MagPro X/R- High