Trial Liners (Neutral and 10 degree hooded)

GUDID 09348215038564

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215038564
NIH Device Record Key303cfb38-332f-4b7c-82ff-d98497811fa3
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrial Liners (Neutral and 10 degree hooded)
Version Model Number112-152-576
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
GS109348215038564 [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

[09348215038564]

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 Liners (Neutral and 10 degree hooded)]

09348215038687112-152-143
09348215038670112-152-142
09348215038663112-152-070
09348215038656112-152-069
09348215038649112-152-068
09348215038632112-152-067
09348215038625112-152-066
09348215038618112-152-065
09348215038601112-152-064
09348215038595112-152-063
09348215038588112-152-062
09348215038571112-152-061
09348215038564112-152-576
09348215038557112-152-169
09348215038540112-152-168
09348215038533112-152-167
09348215038526112-152-166
09348215038519112-152-165
09348215038502112-152-164
09348215038496112-152-163
09348215038489112-152-162
09348215038472112-152-161
09348215038465112-152-160
09348215038458112-152-159
09348215038441112-152-158
09348215038434112-152-157
09348215038427112-152-156

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