TriVerse Femoral Trial PS Insert

GUDID 09348215098520

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215098520
• NIH Device Record Key: 682261bc-c3aa-492f-a973-d2b4d6d00cc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriVerse Femoral Trial PS Insert
• Version Model Number: 02-039-15-4067
• 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	09348215098520 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222380

FDA Product Code

• HWT: Template

Sterilization

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

[09348215098520]

Moist Heat or Steam Sterilization

[09348215098520]

Moist Heat or Steam Sterilization

[09348215098520]

Moist Heat or Steam Sterilization

[09348215098520]

Moist Heat or Steam Sterilization

[09348215098520]

Moist Heat or Steam Sterilization

[09348215098520]

Moist Heat or Steam Sterilization

[09348215098520]

Moist Heat or Steam Sterilization

[09348215098520]

Moist Heat or Steam Sterilization

[09348215098520]

Moist Heat or Steam Sterilization

[09348215098520]

Moist Heat or Steam Sterilization

[09348215098520]

Moist Heat or Steam Sterilization

[09348215098520]

Moist Heat or Steam Sterilization

[09348215098520]

Moist Heat or Steam Sterilization

[09348215098520]

Moist Heat or Steam Sterilization

[09348215098520]

Moist Heat or Steam Sterilization

[09348215098520]

Moist Heat or Steam Sterilization

[09348215098520]

Moist Heat or Steam Sterilization

[09348215098520]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-28
• Device Publish Date: 2023-02-20

On-Brand Devices [TriVerse Femoral Trial PS Insert]

• 09348215098568: 02-039-15-4080
• 09348215098551: 02-039-15-4075
• 09348215098544: 02-039-15-4072
• 09348215098537: 02-039-15-4070
• 09348215098520: 02-039-15-4067
• 09348215098513: 02-039-15-4065
• 09348215098506: 02-039-15-4062
• 09348215098490: 02-039-15-4060
• 09348215098483: 02-039-15-4057
• 09348215098476: 02-039-15-4055
• 09348215097820: 122-22-1180
• 09348215097813: 122-22-1175
• 09348215097806: 122-22-1172
• 09348215097790: 122-22-1170
• 09348215097783: 122-22-1167
• 09348215097776: 122-22-1165
• 09348215097769: 122-22-1162
• 09348215097752: 122-22-1160
• 09348215097745: 122-22-1157
• 09348215097738: 122-22-1155