EASS GPBOTN

GUDID 09353903030003

Griplasty System - Base of Thumb with Needles

FIELD ORTHOPAEDICS PTY LTD

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 09353903030003
• NIH Device Record Key: db0778ad-dcf6-46f5-9cf6-53e16f8078db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EASS
• Version Model Number: 1
• Catalog Number: GPBOTN
• Company DUNS: 744008914
• Company Name: FIELD 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	09353903030003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241695

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-27
• Device Publish Date: 2024-09-19

Devices Manufactured by FIELD ORTHOPAEDICS PTY LTD

• 09353903030003 - EASS: 2024-09-27Griplasty System - Base of Thumb with Needles
• 09353903030003 - EASS: 2024-09-27 Griplasty System - Base of Thumb with Needles
• 09353903000228 - FO Micro Screw System: 2023-09-18 0.6 Single-ended Trocar K-wire 70mm 5/pkg
• 09353903000310 - FO Micro Screw System: 2023-09-18 0.6 Double-ended Trocar K-wire 70mm 5/pkg
• 09353903000327 - FO Micro Screw System: 2023-09-18 0.8 Double-ended Trocar K-wire 70mm 5/pkg
• 09353903000334 - FO Micro Screw System: 2023-09-18 1.0 Double-ended Trocar K-wire 150mm 5/pkg
• 09353903000341 - FO Micro Screw System: 2023-09-18 1.2 Double-ended Trocar K-wire 150mm 5/pkg
• 09353903000358 - FO Micro Screw System: 2023-09-18 1.6 Double-ended Trocar K-wire 150mm 5/pkg
• 09353903000365 - FO Micro Screw System: 2023-09-18 2.0 Double-ended Trocar K-wire 150mm 5/pkg