Trial Cups

GUDID 09348215038885

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215038885
NIH Device Record Keycea9c1c2-1305-4af1-88e4-8add3d762ff4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrial Cups
Version Model Number112-152-197
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY LTD
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

Device Identifiers

Device Issuing AgencyDevice ID
GS109348215038885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215038885]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-06-18
Device Publish Date2018-10-02

On-Brand Devices [Trial Cups]

09348215038991112-152-578
09348215038984112-152-574
09348215038977112-152-573
09348215038960112-152-205
09348215038953112-152-204
09348215038946112-152-203
09348215038939112-152-202
09348215038922112-152-201
09348215038915112-152-200
09348215038908112-152-199
09348215038892112-152-198
09348215038885112-152-197
09348215038878112-152-196
09348215038861112-152-195
09348215038854112-152-194
09348215038847112-152-193
09348215038830112-152-192
09348215038823112-152-191

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