ENVISION 3D: LIGHT HANDLE

GUDID 00627843746669

7D Surgical Inc

Optical surgical navigation device tracking system workstation, mobile Optical surgical navigation device tracking system workstation, mobile Optical surgical navigation device tracking system workstation, mobile Optical surgical navigation device tracking system workstation, mobile Optical surgical navigation device tracking system workstation, mobile Optical surgical navigation device tracking system workstation, mobile Optical surgical navigation device tracking system workstation, mobile Optical surgical navigation device tracking system workstation, mobile Optical surgical navigation device tracking system workstation, mobile Optical surgical navigation device tracking system workstation, mobile Optical surgical navigation device tracking system workstation, mobile Optical surgical navigation device tracking system workstation, mobile Optical surgical navigation device tracking system workstation, mobile Optical surgical navigation device tracking system workstation, mobile Optical surgical navigation device tracking system workstation, mobile Optical surgical navigation device tracking system workstation, mobile Optical surgical navigation device tracking system workstation, mobile Optical surgical navigation device tracking system workstation, mobile Optical surgical navigation device tracking system workstation, mobile
Primary Device ID00627843746669
NIH Device Record Key4af14f54-239f-4e19-8b44-5177e8493815
Commercial Distribution StatusIn Commercial Distribution
Brand NameENVISION 3D: LIGHT HANDLE
Version Model Number11-0005
Company DUNS203460472
Company Name7D Surgical Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100627843746669 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00627843746669]

Moist Heat or Steam Sterilization


[00627843746669]

Moist Heat or Steam Sterilization


[00627843746669]

Moist Heat or Steam Sterilization


[00627843746669]

Moist Heat or Steam Sterilization


[00627843746669]

Moist Heat or Steam Sterilization


[00627843746669]

Moist Heat or Steam Sterilization


[00627843746669]

Moist Heat or Steam Sterilization


[00627843746669]

Moist Heat or Steam Sterilization


[00627843746669]

Moist Heat or Steam Sterilization


[00627843746669]

Moist Heat or Steam Sterilization


[00627843746669]

Moist Heat or Steam Sterilization


[00627843746669]

Moist Heat or Steam Sterilization


[00627843746669]

Moist Heat or Steam Sterilization


[00627843746669]

Moist Heat or Steam Sterilization


[00627843746669]

Moist Heat or Steam Sterilization


[00627843746669]

Moist Heat or Steam Sterilization


[00627843746669]

Moist Heat or Steam Sterilization


[00627843746669]

Moist Heat or Steam Sterilization


[00627843746669]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-09-12

Devices Manufactured by 7D Surgical Inc

00628341520690 - 7D Surgical Universal Clamp (SeaSpine Adapter)2022-01-19
00628341520706 - 7D Surgical Inserter, Lumbar2022-01-10
00628341520713 - 7D Surgical Navigation Guide, T-Handle2022-01-10
00628341520720 - 7D Surgical Facet Array Adaptor2022-01-10
00628341520249 - 7D Surgical Modular 2.2mm Drill Bit2022-01-06
00628341520218 - 7D Surgical FlashLock 22021-12-24
00628341520225 - 7D Surgical FlashLock 32021-12-24
00628341520645 - 7D Surgical Ratcheting Handle, 1/4" Square2021-12-24

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