7D Surgical Registration Frame

GUDID 00628341520553

7D Surgical Inc

Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use
Primary Device ID00628341520553
NIH Device Record Keyd633ab2c-11f4-4b73-bdc5-e020c1024ef8
Commercial Distribution StatusIn Commercial Distribution
Brand Name7D Surgical Registration Frame
Version Model Number11-0066
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 Usetrue
Lot Batchtrue
Serial Numberfalse
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
GS100628341520553 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


[00628341520553]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-04
Device Publish Date2021-07-27

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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