GoDirect® Implant Screw-Receiving Top 4500-61
GUDID 10841307109228
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed| Primary Device ID | 10841307109228 |
| NIH Device Record Key | 87a81190-470f-44c7-9a8f-098ad73bfdc7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GoDirect® Implant Screw-Receiving Top |
| Version Model Number | 4500-61 |
| Catalog Number | 4500-61 |
| Company DUNS | 868856969 |
| Company Name | IMPLANT DIRECT SYBRON MANUFACTURING 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841307109228 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K090234
FDA Product Code
| NHA | Abutment, Implant, Dental, Endosseous |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
[10841307109228]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2015-09-14 |
On-Brand Devices [GoDirect® Implant Screw-Receiving Top]
| 10841307109235 | 4500-62 |
| 10841307109228 | 4500-61 |
Trademark Results [GoDirect]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GODIRECT 88213357 5793539 Live/Registered |
Associates for the Advancement of Musculoskeletal Innovation, Inc. 2018-12-01 |
 GODIRECT 87326482 5295254 Live/Registered |
Honeywell International Inc. 2017-02-07 |
 GODIRECT 86825571 5247109 Live/Registered |
Honeywell International Inc. 2015-11-19 |
 GODIRECT 86664931 4931272 Live/Registered |
Plavan Commercial Fueling, Inc. 2015-06-17 |
 GODIRECT 86014421 not registered Dead/Abandoned |
CORE ORTHOPAEDICS, INC. 2013-07-18 |
 GODIRECT 85395850 4141754 Live/Registered |
Implant Direct Sybron International LLC 2011-08-11 |
 GODIRECT 77961974 3972491 Dead/Cancelled |
eWinWin, Inc. 2010-03-18 |
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