DIRECTguide™ Step Drill GSD2.3-8
GUDID 10841307128243
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable| Primary Device ID | 10841307128243 |
| NIH Device Record Key | 6900beda-4f8c-4576-8017-eb91229893d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIRECTguide™ Step Drill |
| Version Model Number | GSD2.3-8 |
| Catalog Number | GSD2.3-8 |
| 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 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 Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841307128243 [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 |
[10841307128243]
Moist Heat or Steam Sterilization
[10841307128243]
Moist Heat or Steam Sterilization
[10841307128243]
Moist Heat or Steam Sterilization
[10841307128243]
Moist Heat or Steam Sterilization
[10841307128243]
Moist Heat or Steam Sterilization
[10841307128243]
Moist Heat or Steam Sterilization
[10841307128243]
Moist Heat or Steam Sterilization
[10841307128243]
Moist Heat or Steam Sterilization
[10841307128243]
Moist Heat or Steam Sterilization
[10841307128243]
Moist Heat or Steam Sterilization
[10841307128243]
Moist Heat or Steam Sterilization
[10841307128243]
Moist Heat or Steam Sterilization
[10841307128243]
Moist Heat or Steam Sterilization
[10841307128243]
Moist Heat or Steam Sterilization
[10841307128243]
Moist Heat or Steam Sterilization
[10841307128243]
Moist Heat or Steam Sterilization
[10841307128243]
Moist Heat or Steam Sterilization
[10841307128243]
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 |
On-Brand Devices [DIRECTguide™ Step Drill]
| 10841307128540 | GSD2.0-6 |
| 10841307128533 | GSD4.8-16 |
| 10841307128526 | GSD4.8-13 |
| 10841307128519 | GSD4.8-11 |
| 10841307128502 | GSD4.8-10 |
| 10841307128496 | GSD4.8-8 |
| 10841307128489 | GSD4.4-16 |
| 10841307128472 | GSD4.4-13 |
| 10841307128465 | GSD4.4-11 |
| 10841307128458 | GSD4.4-10 |
| 10841307128441 | GSD4.4-8 |
| 10841307128434 | GSD3.8-16 |
| 10841307128427 | GSD3.8-13 |
| 10841307128410 | GSD3.8-11 |
| 10841307128403 | GSD3.8-10 |
| 10841307128397 | GSD3.8-8 |
| 10841307128380 | GSD3.4-16 |
| 10841307128373 | GSD3.4-13 |
| 10841307128366 | GSD3.4-11 |
| 10841307128359 | GSD3.4-10 |
| 10841307128342 | GSD3.4-8 |
| 10841307128335 | GSD2.8-16 |
| 10841307128328 | GSD2.8-13 |
| 10841307128311 | GSD2.8-11 |
| 10841307128304 | GSD2.8-10 |
| 10841307128298 | GSD2.8-8 |
| 10841307128281 | GSD2.3-16 |
| 10841307128274 | GSD2.3-13 |
| 10841307128267 | GSD2.3-11 |
| 10841307128250 | GSD2.3-10 |
| 10841307128243 | GSD2.3-8 |
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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