ENVISION 3D: IMAGE GUIDANCE SYSTEM

GUDID 00627843746614

7D Surgical Inc

Optical surgical navigation device tracking system workstation, mobile

• Primary Device ID: 00627843746614
• NIH Device Record Key: 12790be7-40ad-4af9-9734-7d7a5886115c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENVISION 3D: IMAGE GUIDANCE SYSTEM
• Version Model Number: 10-0001
• 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	00627843746614 [Primary]

FDA Product Code

• OLO: Orthopedic 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: 2
• Public Version Date: 2018-03-29
• 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