Ligament Balancing Block

GUDID 09348215074029

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic implant aiming/guiding block, reusable
Primary Device ID09348215074029
NIH Device Record Key3c977eab-c06f-453c-8391-ba8c6254447b
Commercial Distribution StatusIn Commercial Distribution
Brand NameLigament Balancing Block
Version Model Number122-15-0233
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS109348215074029 [Primary]

FDA Product Code

MDMInstrument, Manual, Surgical, General Use

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215074029]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-02
Device Publish Date2020-06-24

On-Brand Devices [Ligament Balancing Block]

09348215041304122-10-0233
09348215056766122-102-231
09348215062002122-18-0397
09348215074029122-15-0233
09348215046279122-16-0354

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