Duo-Grip™ Fixation Screw (2 pieces) 1000-19
GUDID 10841307108788
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Dental implant suprastructure, permanent, preformed| Primary Device ID | 10841307108788 |
| NIH Device Record Key | e0bd1bac-cf63-43fb-9d87-73e18e6d7283 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Duo-Grip™ Fixation Screw (2 pieces) |
| Version Model Number | 1000-19 |
| Catalog Number | 1000-19 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841307108781 [Unit of Use] |
| GS1 | 10841307108788 [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 |
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
Moist Heat or Steam Sterilization
[10841307108788]
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 [Duo-Grip™ Fixation Screw (2 pieces)]
| 10841307109044 | 1000-42 |
| 10841307109037 | 1000-41 |
| 10841307108788 | 1000-19 |
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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