Duo-Grip™ Fixation Screw Extra Short 1000-19S
GUDID 00841307129595
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| Primary Device ID | 00841307129595 |
| NIH Device Record Key | 81aed2be-7010-44a7-9960-2618e409349a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Duo-Grip™ Fixation Screw Extra Short |
| Version Model Number | 1000-19S |
| Catalog Number | 1000-19S |
| Company DUNS | 868856969 |
| Company Name | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
| Device Count | 2 |
| 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
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841307129595 [Unit of Use] |
| GS1 | 10841307129592 [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 |
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-20 |
| Device Publish Date | 2024-03-12 |
Devices Manufactured by IMPLANT DIRECT SYBRON MANUFACTURING LLC
| 00841307129519 - Long Fixation Screw | 2024-03-20 |
| 00841307129526 - Dual-Grip™ Long Fixation Screw | 2024-03-20 |
| 00841307129533 - Dual-Grip™ Long Fixation Screw | 2024-03-20 |
| 00841307129540 - Long Fixation Screw | 2024-03-20 |
| 00841307129557 - Fixation Screw | 2024-03-20 |
| 00841307129571 - Duo-Grip™ Long Fixation Screw | 2024-03-20 |
| 00841307129588 - Duo-Grip™ Fixation Screw | 2024-03-20 |
| 00841307129595 - Duo-Grip™ Fixation Screw Extra Short | 2024-03-20 |
| 00841307129595 - Duo-Grip™ Fixation Screw Extra Short | 2024-03-20 |
Trademark Results [Duo-Grip]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DUO-GRIP 86814256 not registered Dead/Abandoned |
Marketing and Sales Management Corp. 2015-11-09 |
 DUO-GRIP 75015112 not registered Dead/Abandoned |
Chatwins Group, Inc. 1995-11-06 |
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