TECHFIT GCGTI
GUDID 00860010801635
Le Fort Surgical Guide - Ti
Techfit Digital Surgery, Inc.
Custom-made orthopaedic/craniofacial surgical guide| Primary Device ID | 00860010801635 |
| NIH Device Record Key | 29837d58-b6be-4ac0-ab45-e24337e9d586 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TECHFIT |
| Version Model Number | 0 |
| Catalog Number | GCGTI |
| 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 | 00860010801635 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K230276
FDA Product Code
| DZJ | Driver, Wire, And Bone Drill, Manual |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
[00860010801635]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-14 |
| Device Publish Date | 2023-08-04 |
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 |
| 00860012759439 | Digitally Integrated Surgical Reconstruction Platform - DISRP |
| 00860012759460 | Maxilla Cutting Guide Ti |
| 00860012759453 | Mandible Cutting Guide Ti |
| 00860012759446 | Fibula cutting guide Ti |
Trademark Results [TECHFIT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TECHFIT 90075282 not registered Live/Pending |
Wellness Solutions Inc SRL 2020-07-27 |
 TECHFIT 87868205 5611357 Live/Registered |
adidas International Marketing B.V. 2018-04-09 |
 TECHFIT 78846613 4415121 Live/Registered |
adidas International Marketing B.V. 2006-03-27 |
 TECHFIT 75597573 2416342 Dead/Cancelled |
YAZAKI CORPORATION 1998-12-01 |
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