TLC Uni Knee Meniscal Insert

GUDID 09348215077709

Unicondylar knee prosthesis

Primary Device ID	09348215077709
NIH Device Record Key	37f736f7-1aae-4a7d-814a-fdf5310dae02
Commercial Distribution Status	In Commercial Distribution
Brand Name	TLC Uni Knee Meniscal Insert
Version Model Number	121-21-2601
Company DUNS	751993028
Company Name	SIGNATURE ORTHOPAEDICS PTY LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	09348215077709 [Primary]

HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Steralize Prior To Use	false
Device Is Sterile	true