Mini Stealth 911002-0001-P01

GUDID 00811714036052

Mini Stealth Castle Guide Tube

RESPONSIVE ORTHOPEDICS LLC

Surgical drill guide, reusable
Primary Device ID00811714036052
NIH Device Record Key69a72eec-4dd5-4583-b748-4eebb8a48eae
Commercial Distribution StatusIn Commercial Distribution
Brand NameMini Stealth
Version Model Number911002-0001-P01
Catalog Number911002-0001-P01
Company DUNS002745858
Company NameRESPONSIVE ORTHOPEDICS LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
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
GS100811714036052 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00811714036052]

Moist Heat or Steam Sterilization


[00811714036052]

Moist Heat or Steam Sterilization


[00811714036052]

Moist Heat or Steam Sterilization


[00811714036052]

Moist Heat or Steam Sterilization


[00811714036052]

Moist Heat or Steam Sterilization


[00811714036052]

Moist Heat or Steam Sterilization


[00811714036052]

Moist Heat or Steam Sterilization


[00811714036052]

Moist Heat or Steam Sterilization


[00811714036052]

Moist Heat or Steam Sterilization


[00811714036052]

Moist Heat or Steam Sterilization


[00811714036052]

Moist Heat or Steam Sterilization


[00811714036052]

Moist Heat or Steam Sterilization


[00811714036052]

Moist Heat or Steam Sterilization


[00811714036052]

Moist Heat or Steam Sterilization


[00811714036052]

Moist Heat or Steam Sterilization


[00811714036052]

Moist Heat or Steam Sterilization


[00811714036052]

Moist Heat or Steam Sterilization


[00811714036052]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-09
Device Publish Date2024-04-01

On-Brand Devices [Mini Stealth]

00811714035864Mini Stealth Instruments
00811714035758Mini Stealth Instrument Tray
00811714035727Mini Stealth Blunt Probe
00811714035703Mini Stealth Probe
00811714035680Mini Stealth Castle Guide Tube
00811714035666Mini Stealth Drill 2.1mm
00811714036076Mini Stealth Blunt Probe
00811714036069Mini Stealth Probe
00811714036052Mini Stealth Castle Guide Tube
00811714036045Mini Stealth Drill 2.1mm

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