DIRECTguide™ Surgical Kit - Empty GSK-E
GUDID 10841307128212
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable| Primary Device ID | 10841307128212 |
| NIH Device Record Key | 71207176-35fb-47c4-909a-5e742e0e612b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIRECTguide™ Surgical Kit - Empty |
| Version Model Number | GSK-E |
| Catalog Number | GSK-E |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | 10841307128212 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231087
FDA Product Code
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10841307128212]
Moist Heat or Steam Sterilization
[10841307128212]
Moist Heat or Steam Sterilization
[10841307128212]
Moist Heat or Steam Sterilization
[10841307128212]
Moist Heat or Steam Sterilization
[10841307128212]
Moist Heat or Steam Sterilization
[10841307128212]
Moist Heat or Steam Sterilization
[10841307128212]
Moist Heat or Steam Sterilization
[10841307128212]
Moist Heat or Steam Sterilization
[10841307128212]
Moist Heat or Steam Sterilization
[10841307128212]
Moist Heat or Steam Sterilization
[10841307128212]
Moist Heat or Steam Sterilization
[10841307128212]
Moist Heat or Steam Sterilization
[10841307128212]
Moist Heat or Steam Sterilization
[10841307128212]
Moist Heat or Steam Sterilization
[10841307128212]
Moist Heat or Steam Sterilization
[10841307128212]
Moist Heat or Steam Sterilization
[10841307128212]
Moist Heat or Steam Sterilization
[10841307128212]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-21 |
| Device Publish Date | 2023-11-13 |
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 |
Trademark Results [DIRECTguide]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIRECTGUIDE 97918054 not registered Live/Pending |
Implant Direct Sybron International LLC 2023-05-03 |
 DIRECTGUIDE 74699809 2095674 Dead/Cancelled |
VOGEL SATELLITE TV PUBLISHING INC. 1995-07-11 |
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