Distal Reduces Aria Broach Size 9

GUDID 09348215073435

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic broach
Primary Device ID09348215073435
NIH Device Record Key4dc7b81f-4e45-4896-b1de-3c8b877264c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDistal Reduces Aria Broach Size 9
Version Model Number111-20-6909
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
GS109348215073435 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215073435]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-01
Device Publish Date2020-06-23

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