TECHFIT MAPMANIFZD

GUDID 00860011469209

Complete Maxillofacial Model (fused)

Techfit Digital Surgery, Inc.

Custom-made organ/bone anatomy model

• Primary Device ID: 00860011469209
• NIH Device Record Key: 614a8b90-6ff6-4446-be9b-deef42f3edc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TECHFIT
• Version Model Number: 0
• Catalog Number: MAPMANIFZD
• Company DUNS: 117050279
• Company Name: Techfit Digital Surgery, Inc.
• 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: true
• Lot Batch: true
• Serial Number: true
• 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	00860011469209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222577

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-26
• Device Publish Date: 2023-12-18

On-Brand Devices [TECHFIT]

• 00860007543449: Patient-Specific Maxillofacial/midface implant-Ti
• 00860007543425: Patient-Specific Maxillary Implant - Titanium - high complexity
• 00860007543401: Patient-Specific Mandible Implant - Titanium - high complexity
• 00860007543432: Maxillomandibular Anatomic Diagnostic Model CL
• 00860007543418: Patient-Specific Maxillary Implant - Titanium - high complexity
• 00860010801680: Screw metal sleeve
• 00860010801673: Slot metal sleeve
• 00860010801666: Drill metal sleeve
• 00860010801659: Genioplasty Surgical Guide - Ti
• 00860010801642: Genioplasty Surgical Guide with dental support - Ti
• 00860010801635: Le Fort Surgical Guide - Ti
• 00860010801628: Le Fort Surgical Guide with dental support - TI
• 00860010801611: Genioplasty Surgical Guide with Splint - Resin
• 00860010801604: Genioplasty Surgical Guide - Resin
• 00860007543494: Le Fort Surgical Guide - Wall with Splints - Resin
• 00860007543487: Le Fort Surgical Guide - Slots with Splints - Resin
• 00860007543470: Le Fort Surgical Guide - Wall Resin
• 00860007543463: Le Fort Surgical Guide - Slots Resin
• 00860007543456: Final Orthognathic Surgical Splint
• 00860011469209: Complete Maxillofacial Model (fused)
• 00860010801697: Mandible And Maxilla Model - 2 Piece
• 00860011469230: BSSO Surgical Guide - TI
• 00860011469223: Palatal Orthognathic Surgical Splint - Resin
• 00860011469216: Palatal Orthognathic Surgical Splint - TI
• 00860011469254: Maxilla Model
• 00860011469247: Mandible Model
• 00860011469285: Condyle guide positioning Ti
• 00860012759422: Palatal Orthog Surgical Splint Digital
• 00860012759415: Interm Orthog Surgical Splint Digital
• 00860012759408: Final Orthog Surgical Splint Digital