7D Surgical Bit Guide – Aggressive Insert

GUDID 00628341520294

7D Surgical Inc

Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable
Primary Device ID00628341520294
NIH Device Record Key03085c79-b03f-4dcb-be16-1758b30d9076
Commercial Distribution StatusIn Commercial Distribution
Brand Name7D Surgical Bit Guide – Aggressive Insert
Version Model Number11-0042
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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100628341520294 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00628341520294]

Moist Heat or Steam Sterilization


[00628341520294]

Moist Heat or Steam Sterilization


[00628341520294]

Moist Heat or Steam Sterilization


[00628341520294]

Moist Heat or Steam Sterilization


[00628341520294]

Moist Heat or Steam Sterilization


[00628341520294]

Moist Heat or Steam Sterilization


[00628341520294]

Moist Heat or Steam Sterilization


[00628341520294]

Moist Heat or Steam Sterilization


[00628341520294]

Moist Heat or Steam Sterilization


[00628341520294]

Moist Heat or Steam Sterilization


[00628341520294]

Moist Heat or Steam Sterilization


[00628341520294]

Moist Heat or Steam Sterilization


[00628341520294]

Moist Heat or Steam Sterilization


[00628341520294]

Moist Heat or Steam Sterilization


[00628341520294]

Moist Heat or Steam Sterilization


[00628341520294]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-12
Device Publish Date2021-10-04

Devices Manufactured by 7D Surgical Inc

00628341520263 - 7D Surgical Drill Guide2021-10-12
00628341520270 - 7D Surgical Trocar Insert2021-10-12
00628341520287 - 7D Surgical Bit Guide – 3.0mm Insert2021-10-12
00628341520294 - 7D Surgical Bit Guide – Aggressive Insert2021-10-12
00628341520294 - 7D Surgical Bit Guide – Aggressive Insert2021-10-12
00628341520300 - 7D Surgical 3.0mm Drill Bit2021-10-12
00628341520317 - 7D Surgical 2.1mm Drill Bit2021-10-12
00628341520324 - 7D Surgical Drill Bit Stopper2021-10-12
00628341520591 - 7D Surgical T-Handle Chuck2021-10-12

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.