Signature ONE

GUDID 00887868522987

Alliance Glenoid Shoulder Guide and Bone Model Left

Orthosoft Inc

Orthopaedic prosthesis implantation instrument, single-use
Primary Device ID00887868522987
NIH Device Record Keyafa5e09b-c658-4a38-a544-b75a68de4065
Commercial Distribution StatusIn Commercial Distribution
Brand NameSignature ONE
Version Model Number20-8090-008-01
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 Kittrue
Device Combination Productfalse
Single Usetrue
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
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
GS100887868522987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QHEShoulder Arthroplasty Implantation System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


[00887868522987]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-28
Device Publish Date2022-07-20

On-Brand Devices [Signature ONE]

00887868522994Alliance Glenoid Shoulder Guide and Bone Model Right
00887868522987Alliance Glenoid Shoulder Guide and Bone Model Left

Trademark Results [Signature ONE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SIGNATURE ONE
SIGNATURE ONE
76238512 2633118 Dead/Cancelled
ADVANCE WATCH CO., LTD.
2001-04-10
SIGNATURE ONE
SIGNATURE ONE
73755868 1536294 Dead/Cancelled
MESA DIAGNOSTICS, INC.
1988-05-04

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