Fixed Screw Driver Handle, 1.7mm

GUDID 00810054090991

Fixed Screw Driver Handle, 1.7mm

AVANTI ORTHOPAEDICS LLC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00810054090991
• NIH Device Record Key: b5f83c81-6264-490f-934e-011f8fef1e95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixed Screw Driver Handle, 1.7mm
• Version Model Number: FH17
• Company DUNS: 043505370
• Company Name: AVANTI ORTHOPAEDICS LLC
• 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

Customer Support Contacts

• Phone: 610 316 7345
• Email: ag.wieczorek.87@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810054090991 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191118

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00810054090991]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-02-19
• Device Publish Date: 2020-06-18

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• 00810054090045 - Volar Fixed Angle Plate, 5 Hole, Right: 2024-02-19 Volar Fixed Angle Plate, 5 Hole, Right
• 00810054090052 - Volar Fixed Plate, Wide, 5 Hole, Left: 2024-02-19 Volar Fixed Plate, Wide, 5 Hole, Left
• 00810054090069 - Volar Fixed Plate, Wide, 5 Hole, Right: 2024-02-19 Volar Fixed Plate, Wide, 5 Hole, Right
• 00810054090076 - Volar PEEK Plate, 3 Hole, Left: 2024-02-19 Volar PEEK Plate, 3 Hole, Left
• 00810054090083 - Volar PEEK Plate, 3 Hole, Right: 2024-02-19 Volar PEEK Plate, 3 Hole, Right