7D Surgical Flex Rod Connector (4.5 mm - 100 mm)

GUDID 00628341521024

7D Surgical ULC

Intraoperative optical-tracking spatial register connector
Primary Device ID00628341521024
NIH Device Record Key330e7750-13ed-4f88-9be0-e37cf703d8a5
Commercial Distribution StatusIn Commercial Distribution
Brand Name7D Surgical Flex Rod Connector (4.5 mm - 100 mm)
Version Model Number11-0113
Company DUNS204326292
Company Name7D Surgical ULC
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 Batchtrue
Serial Numberfalse
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
GS100628341521024 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


[00628341521024]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-28
Device Publish Date2023-08-18

Devices Manufactured by 7D Surgical ULC

00628341521055 - 7D Surgical Iliac Dual Pin Sterilization Tray2024-07-29
00628341520850 - 7D Surgical Reference Clamp (Gator)2023-09-18
00628341521024 - 7D Surgical Flex Rod Connector (4.5 mm - 100 mm)2023-08-28
00628341521024 - 7D Surgical Flex Rod Connector (4.5 mm - 100 mm)2023-08-28
00628341520874 - 7D Surgical Spine Reference Clamp (Multi-Level)2023-08-08
00628341520881 - 7D Surgical Iliac Cannula, 100 mm2023-03-01
00628341520898 - 7D Surgical Iliac Dilator, 100 mm2023-03-01
00628341520904 - 7D Surgical Iliac Cross Pin, 100 mm2023-03-01
00628341520911 - 7D Surgical Iliac Cannula, 150 mm2023-03-01

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.