Hip Instrument Tray

GUDID 09348215098766

SIGNATURE ORTHOPAEDICS PTY LTD

Instrument tray, reusable

Primary Device ID	09348215098766
NIH Device Record Key	25fb623e-0c01-44ca-a89d-37e8167e19d3
Commercial Distribution Status	In Commercial Distribution
Brand Name	Hip Instrument Tray
Version Model Number	192-20-0176
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	false
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	09348215098766 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153131

FDA Product Code

KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

[09348215098766]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-02-22
Device Publish Date	2022-02-14

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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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