Trial Liners (20 degree hooded)

GUDID 09348215038748

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215038748
NIH Device Record Keya88fc0fe-3e31-4f46-bc7d-d60568918b95
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrial Liners (20 degree hooded)
Version Model Number112-152-521
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
GS109348215038748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215038748]

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 (20 degree hooded)]

09348215038816112-152-528
09348215038809112-152-527
09348215038793112-152-526
09348215038786112-152-525
09348215038779112-152-524
09348215038762112-152-523
09348215038755112-152-522
09348215038748112-152-521
09348215038731112-152-520
09348215038724112-152-519
09348215038717112-152-518
09348215038700112-152-517
09348215038694112-152-516

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