SignaSure Cup Backing Plate

GUDID 09348215084813

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 09348215084813
• NIH Device Record Key: 080128f1-5762-47a9-ac84-6869104017ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SignaSure Cup Backing Plate
• Version Model Number: 112-35-0750
• 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	09348215084813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211742

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

[09348215084813]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-07
• Device Publish Date: 2022-01-28

On-Brand Devices [SignaSure Cup Backing Plate]

• 09348215084882: 112-35-0764
• 09348215084875: 112-35-0762
• 09348215084868: 112-35-0760
• 09348215084851: 112-35-0758
• 09348215084844: 112-35-0756
• 09348215084837: 112-35-0754
• 09348215084820: 112-35-0752
• 09348215084813: 112-35-0750
• 09348215084806: 112-35-0748
• 09348215084790: 112-35-0746
• 09348215084783: 112-35-0744
• 09348215084776: 112-35-0742