Dual-Grip™ Long Fixation Screw 1000-12
GUDID 00841307129533
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Dental implant suprastructure, permanent, preformed| Primary Device ID | 00841307129533 |
| NIH Device Record Key | 7f142665-1768-47fd-bcf1-585b75052e69 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dual-Grip™ Long Fixation Screw |
| Version Model Number | 1000-12 |
| Catalog Number | 1000-12 |
| 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 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841307129533 [Unit of Use] |
| GS1 | 10841307129530 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061319
FDA Product Code
| NHA | Abutment, Implant, Dental, Endosseous |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841307129533]
Moist Heat or Steam Sterilization
[00841307129533]
Moist Heat or Steam Sterilization
[00841307129533]
Moist Heat or Steam Sterilization
[00841307129533]
Moist Heat or Steam Sterilization
[00841307129533]
Moist Heat or Steam Sterilization
[00841307129533]
Moist Heat or Steam Sterilization
[00841307129533]
Moist Heat or Steam Sterilization
[00841307129533]
Moist Heat or Steam Sterilization
[00841307129533]
Moist Heat or Steam Sterilization
[00841307129533]
Moist Heat or Steam Sterilization
[00841307129533]
Moist Heat or Steam Sterilization
[00841307129533]
Moist Heat or Steam Sterilization
[00841307129533]
Moist Heat or Steam Sterilization
[00841307129533]
Moist Heat or Steam Sterilization
[00841307129533]
Moist Heat or Steam Sterilization
[00841307129533]
Moist Heat or Steam Sterilization
[00841307129533]
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 |
On-Brand Devices [Dual-Grip™ Long Fixation Screw]
| 00841307129533 | 1000-12 |
| 00841307129526 | 1000-11 |
Trademark Results [Dual-Grip]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DUAL-GRIP 90241709 not registered Live/Pending |
Power Stop LLC 2020-10-08 |
 DUAL-GRIP 85117881 3954407 Live/Registered |
Sofa Mart, LLC 2010-08-27 |
 DUAL-GRIP 78522795 3252310 Live/Registered |
CONTITECH USA, INC. 2004-11-24 |
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