All Poly Monotrial

GUDID 09348215063818

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

Primary Device ID	09348215063818
NIH Device Record Key	50078113-85d0-46d0-b4db-26fdb0a3fb03
Commercial Distribution Status	In Commercial Distribution
Brand Name	All Poly Monotrial
Version Model Number	122-18-0350
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	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09348215063818 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K170613
Premarket Notification: K181530

FDA Product Code

Template

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-06-11
Device Publish Date	2020-06-03

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

09348215135362 - World Cup Liner – Neutral Lateralised	2024-12-11
09348215135379 - World Cup Liner – Neutral Lateralised	2024-12-11
09348215135386 - World Cup Liner – Neutral Lateralised	2024-12-11
09348215135393 - World Cup Liner – Neutral Lateralised	2024-12-11
09348215135409 - World Cup Liner – Neutral Lateralised	2024-12-11
09348215135416 - World Cup Liner – Neutral Lateralised	2024-12-11
09348215135423 - World Cup Liner – Neutral Lateralised	2024-12-11
09348215135430 - World Cup Liner – Neutral Lateralised	2024-12-11

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