ENVISION 3D: PEDICLE PROBE

GUDID 00627843746638

7D Surgical Inc

Optical surgical navigation device tracking system spatial register connector Optical surgical navigation device tracking system spatial register connector Optical surgical navigation device tracking system spatial register connector Optical surgical navigation device tracking system spatial register connector Optical surgical navigation device tracking system spatial register connector Optical surgical navigation device tracking system spatial register connector Optical surgical navigation device tracking system spatial register connector Optical surgical navigation device tracking system spatial register connector Optical surgical navigation device tracking system spatial register connector Optical surgical navigation device tracking system spatial register connector Optical surgical navigation device tracking system spatial register connector Optical surgical navigation device tracking system spatial register connector Optical surgical navigation device tracking system spatial register connector Optical surgical navigation device tracking system spatial register connector Optical surgical navigation device tracking system spatial register connector Optical surgical navigation device tracking system spatial register connector Optical surgical navigation device tracking system spatial register connector Optical surgical navigation device tracking system spatial register connector Optical surgical navigation device tracking system spatial register connector Intraoperative optical-tracking spatial register connector Intraoperative optical-tracking spatial register connector Intraoperative optical-tracking spatial register connector Intraoperative optical-tracking spatial register connector Intraoperative optical-tracking spatial register connector Intraoperative optical-tracking spatial register connector Intraoperative optical-tracking spatial register connector Surgical optical-tracking spatial marker connector Surgical optical-tracking spatial marker connector Surgical optical-tracking spatial marker connector Surgical optical-tracking spatial marker connector Surgical optical-tracking spatial marker connector Surgical optical-tracking spatial marker connector Surgical optical-tracking spatial marker connector Surgical optical-tracking spatial marker connector Surgical optical-tracking spatial marker connector Surgical optical-tracking spatial marker connector Surgical optical-tracking spatial marker connector Surgical optical-tracking spatial marker connector Surgical optical-tracking spatial marker connector

• Primary Device ID: 00627843746638
• NIH Device Record Key: 00f16f7e-777c-499e-8ffc-3013fc21cba8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENVISION 3D: PEDICLE PROBE
• Version Model Number: 11-0002
• Company DUNS: 203460472
• Company Name: 7D Surgical Inc
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627843746638 [Primary]

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

[00627843746638]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-10-22
• Device Publish Date: 2017-09-12

Devices Manufactured by 7D Surgical Inc

• 00628341520690 - 7D Surgical Universal Clamp (SeaSpine Adapter): 2022-01-19
• 00628341520706 - 7D Surgical Inserter, Lumbar: 2022-01-10
• 00628341520713 - 7D Surgical Navigation Guide, T-Handle: 2022-01-10
• 00628341520720 - 7D Surgical Facet Array Adaptor: 2022-01-10
• 00628341520249 - 7D Surgical Modular 2.2mm Drill Bit: 2022-01-06
• 00628341520218 - 7D Surgical FlashLock 2: 2021-12-24
• 00628341520225 - 7D Surgical FlashLock 3: 2021-12-24
• 00628341520645 - 7D Surgical Ratcheting Handle, 1/4" Square: 2021-12-24