DIRECTguide™ Guided Step Drill GSD2.3-13
GUDID 10841307131076
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Fluted surgical drill bit, reusable| Primary Device ID | 10841307131076 |
| NIH Device Record Key | bcde3b37-d7f4-46bf-9e54-c343eb78f51c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIRECTguide™ Guided Step Drill |
| Version Model Number | GSD2.3-13 |
| Catalog Number | GSD2.3-13 |
| 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
| 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 | 10841307131076 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231087
FDA Product Code
| DZI | Drill, Bone, Powered |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10841307131076]
Moist Heat or Steam Sterilization
[10841307131076]
Moist Heat or Steam Sterilization
[10841307131076]
Moist Heat or Steam Sterilization
[10841307131076]
Moist Heat or Steam Sterilization
[10841307131076]
Moist Heat or Steam Sterilization
[10841307131076]
Moist Heat or Steam Sterilization
[10841307131076]
Moist Heat or Steam Sterilization
[10841307131076]
Moist Heat or Steam Sterilization
[10841307131076]
Moist Heat or Steam Sterilization
[10841307131076]
Moist Heat or Steam Sterilization
[10841307131076]
Moist Heat or Steam Sterilization
[10841307131076]
Moist Heat or Steam Sterilization
[10841307131076]
Moist Heat or Steam Sterilization
[10841307131076]
Moist Heat or Steam Sterilization
[10841307131076]
Moist Heat or Steam Sterilization
[10841307131076]
Moist Heat or Steam Sterilization
[10841307131076]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-28 |
| Device Publish Date | 2024-05-20 |
Devices Manufactured by IMPLANT DIRECT SYBRON MANUFACTURING LLC
| 10841307131014 - DIRECTguide™ Guided Surgery Kit - Empty | 2024-05-28 |
| 10841307131021 - DIRECTguide™ Guided Surgery Kit - Legacy | 2024-05-28 |
| 10841307131038 - DIRECTguide™ Guided Surgery Kit - Conical | 2024-05-28 |
| 10841307131045 - DIRECTguide™ Guided Step Drill | 2024-05-28 |
| 10841307131052 - DIRECTguide™ Guided Step Drill | 2024-05-28 |
| 10841307131069 - DIRECTguide™ Guided Step Drill | 2024-05-28 |
| 10841307131076 - DIRECTguide™ Guided Step Drill | 2024-05-28 |
| 10841307131076 - DIRECTguide™ Guided Step Drill | 2024-05-28 |
| 10841307131083 - DIRECTguide™ Guided Step Drill | 2024-05-28 |
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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