7D Surgical Drill Guide Verification Insert

GUDID 00628341520768

7D Surgical ULC

Stereotactic surgery system probe, reusable
Primary Device ID00628341520768
NIH Device Record Key0f664857-8732-428c-957c-cb26e289160f
Commercial Distribution StatusIn Commercial Distribution
Brand Name7D Surgical Drill Guide Verification Insert
Version Model Number11-0090
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 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
GS100628341520768 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00628341520768]

Moist Heat or Steam Sterilization


[00628341520768]

Moist Heat or Steam Sterilization


[00628341520768]

Moist Heat or Steam Sterilization


[00628341520768]

Moist Heat or Steam Sterilization


[00628341520768]

Moist Heat or Steam Sterilization


[00628341520768]

Moist Heat or Steam Sterilization


[00628341520768]

Moist Heat or Steam Sterilization


[00628341520768]

Moist Heat or Steam Sterilization


[00628341520768]

Moist Heat or Steam Sterilization


[00628341520768]

Moist Heat or Steam Sterilization


[00628341520768]

Moist Heat or Steam Sterilization


[00628341520768]

Moist Heat or Steam Sterilization


[00628341520768]

Moist Heat or Steam Sterilization


[00628341520768]

Moist Heat or Steam Sterilization


[00628341520768]

Moist Heat or Steam Sterilization


[00628341520768]

Moist Heat or Steam Sterilization


[00628341520768]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-15
Device Publish Date2022-04-07

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
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

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