7D Surgical Universal Array 1 11-0015

GUDID 00628341520041

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 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 ID00628341520041
NIH Device Record Key156b372a-4549-4017-ae00-16e99bc08f0b
Commercial Distribution StatusIn Commercial Distribution
Brand Name7D Surgical Universal Array 1
Version Model Number11-0015
Catalog Number11-0015
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100628341520041 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


[00628341520041]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-04
Device Publish Date2019-11-26

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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