20-8000-010-12

GUDID 00889024304352

Orthosoft Inc

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID00889024304352
NIH Device Record Key171a310e-9d1d-411e-a35a-3f17e415f89c
Commercial Distribution StatusIn Commercial Distribution
Version Model Number20-8000-010-12
Catalog Number20-8000-010-12
Company DUNS205670032
Company NameOrthosoft 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 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

Customer Support Contacts

Phone1(800)-348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)-348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)-348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)-348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)-348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)-348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)-348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)-348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)-348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)-348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)-348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)-348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)-348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)-348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)-348-2759
Emailzimmer.consumerrelations@zimmer.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024304352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024304352]

Moist Heat or Steam Sterilization


[00889024304352]

Moist Heat or Steam Sterilization


[00889024304352]

Moist Heat or Steam Sterilization


[00889024304352]

Moist Heat or Steam Sterilization


[00889024304352]

Moist Heat or Steam Sterilization


[00889024304352]

Moist Heat or Steam Sterilization


[00889024304352]

Moist Heat or Steam Sterilization


[00889024304352]

Moist Heat or Steam Sterilization


[00889024304352]

Moist Heat or Steam Sterilization


[00889024304352]

Moist Heat or Steam Sterilization


[00889024304352]

Moist Heat or Steam Sterilization


[00889024304352]

Moist Heat or Steam Sterilization


[00889024304352]

Moist Heat or Steam Sterilization


[00889024304352]

Moist Heat or Steam Sterilization


[00889024304352]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-07

Devices Manufactured by Orthosoft Inc

00887868578915 - HAMMR™2024-05-01
00887868557873 - ROSA® Shoulder2024-03-14
00887868557880 - ROSA® Shoulder2024-03-14
00887868557897 - ROSA® Shoulder2024-03-14
00887868557903 - ROSA® Shoulder2024-03-14
00887868557910 - ROSA® Shoulder2024-03-14
00887868558078 - ROSA® Shoulder2024-03-14
00887868558092 - ROSA® Shoulder2024-03-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.