Hemostasis Adapter 0010011141

GUDID M58800100111410

Hemostasis Adapter IV Spares, Box, Device Count(5)

STEREOTAXIS, INC.

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• Primary Device ID: M58800100111410
• NIH Device Record Key: 3d740963-7fcc-45b4-ab4b-9388c355907d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemostasis Adapter
• Version Model Number: IV-1
• Catalog Number: 0010011141
• Company DUNS: 024942265
• Company Name: STEREOTAXIS, INC.
• Device Count: 5
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M58800100111410 [Unit of Use]
HIBCC	M58800100111411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071029

FDA Product Code

• DQX: Wire, Guide, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-22
• Device Publish Date: 2021-12-14

Devices Manufactured by STEREOTAXIS, INC.

• M588020004500370 - Navigant: 2023-05-03 The Navigant Navigation Workstation (NWS) is a component of the Magnetic Navigation System (MNS). The MNS with NWS is intended t
• M588001004115110 - Cardiodrive System: 2022-06-14 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
• M588001004115120 - Cardiodrive System: 2022-06-14 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
• M58800100111410 - Hemostasis Adapter: 2021-12-22Hemostasis Adapter IV Spares, Box, Device Count(5)
• M58800100111410 - Hemostasis Adapter: 2021-12-22 Hemostasis Adapter IV Spares, Box, Device Count(5)
• M58800101100010 - Genesis (MNS) with Siemens: 2020-08-28 Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left
• M58800101100030 - Genesis MNS with Model-S: 2020-08-28 "Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left