7D Surgical System

GUDID 00628341520379

7D Surgical Inc

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Primary Device ID00628341520379
NIH Device Record Key3b6e9a30-a280-4663-b31f-a0fd4665f8da
Commercial Distribution StatusIn Commercial Distribution
Brand Name7D Surgical System
Version Model Number10-0001
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100628341520379 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-25
Device Publish Date2019-12-17

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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