Everglade Broach

GUDID 09348215105204

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic broach

• Primary Device ID: 09348215105204
• NIH Device Record Key: 0805a72a-676b-4a5c-bcf3-55a36b597e58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Everglade Broach
• Version Model Number: 111-45-2010
• 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	09348215105204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211505

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[09348215105204]

Moist Heat or Steam Sterilization

[09348215105204]

Moist Heat or Steam Sterilization

[09348215105204]

Moist Heat or Steam Sterilization

[09348215105204]

Moist Heat or Steam Sterilization

[09348215105204]

Moist Heat or Steam Sterilization

[09348215105204]

Moist Heat or Steam Sterilization

[09348215105204]

Moist Heat or Steam Sterilization

[09348215105204]

Moist Heat or Steam Sterilization

[09348215105204]

Moist Heat or Steam Sterilization

[09348215105204]

Moist Heat or Steam Sterilization

[09348215105204]

Moist Heat or Steam Sterilization

[09348215105204]

Moist Heat or Steam Sterilization

[09348215105204]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-29
• Device Publish Date: 2022-08-19

On-Brand Devices [Everglade Broach]

• 09348215105228: 111-45-2012
• 09348215105211: 111-45-2011
• 09348215105204: 111-45-2010
• 09348215105198: 111-45-2009
• 09348215105181: 111-45-2008
• 09348215105174: 111-45-2007
• 09348215105167: 111-45-2006
• 09348215105150: 111-45-2005
• 09348215105143: 111-45-2004
• 09348215105136: 111-45-2003
• 09348215105129: 111-45-2002
• 09348215105112: 111-45-2001
• 09348215105105: 111-45-2000