TGS Field Generator Stand

GUDID 00850002250442

The Field Generator Stand is a reusable device intended to be used with the Stryker ENT Navigation System. The mounting arm provides fixation for the field generator of the navigation system allowing it to be positioned in proximity to the patient creating an EM field.

ENTELLUS MEDICAL, INC.

Mobile medical equipment stand, non-powered

• Primary Device ID: 00850002250442
• NIH Device Record Key: e238ab87-9d2e-4551-bd4f-578fb8bcbdbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TGS Field Generator Stand
• Version Model Number: 8000-014-005
• Company DUNS: 017283879
• Company Name: ENTELLUS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	00850002250442 [Primary]

FDA Product Code

• QLV: Field Generator Positioning Device

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: 2022-01-12
• Device Publish Date: 2022-01-04

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