Aria Broach

GUDID 09348215040307

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic broach
Primary Device ID09348215040307
NIH Device Record Key73769e5c-4b5a-47a9-ba61-e8bdea80be4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAria Broach
Version Model Number111-20-6211
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
GS109348215040307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215040307]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-04
Device Publish Date2018-10-02

On-Brand Devices [Aria Broach]

09348215040314111-20-6212
09348215040307111-20-6211
09348215040291111-20-6210
09348215040284111-20-6209
09348215040277111-20-6208
09348215040260111-20-6207
09348215040253111-20-6206
09348215040246111-20-6205
09348215040239111-20-6204
09348215040222111-20-6203
09348215040215111-20-6202
09348215040208111-20-6201
09348215040192111-20-6200

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