DIRECTguide™ Sleeve Regular (5PK) GSR-Lab
GUDID 00841307128628
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Instrument tray, reusable| Primary Device ID | 00841307128628 |
| NIH Device Record Key | dea09edf-f691-4e1c-a62c-f548e2fa2a6e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIRECTguide™ Sleeve Regular (5PK) |
| Version Model Number | GSR-Lab |
| Catalog Number | GSR-Lab |
| Company DUNS | 868856969 |
| Company Name | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841307128628 [Unit of Use] |
| GS1 | 10841307132158 [Primary] |
FDA Product Code
| NDP | Accessories, Implant, Dental, Endosseous |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841307128628]
Moist Heat or Steam Sterilization
[00841307128628]
Moist Heat or Steam Sterilization
[00841307128628]
Moist Heat or Steam Sterilization
[00841307128628]
Moist Heat or Steam Sterilization
[00841307128628]
Moist Heat or Steam Sterilization
[00841307128628]
Moist Heat or Steam Sterilization
[00841307128628]
Moist Heat or Steam Sterilization
[00841307128628]
Moist Heat or Steam Sterilization
[00841307128628]
Moist Heat or Steam Sterilization
[00841307128628]
Moist Heat or Steam Sterilization
[00841307128628]
Moist Heat or Steam Sterilization
[00841307128628]
Moist Heat or Steam Sterilization
[00841307128628]
Moist Heat or Steam Sterilization
[00841307128628]
Moist Heat or Steam Sterilization
[00841307128628]
Moist Heat or Steam Sterilization
[00841307128628]
Moist Heat or Steam Sterilization
[00841307128628]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-10 |
| Device Publish Date | 2025-01-31 |
On-Brand Devices [DIRECTguide™ Sleeve Regular (5PK)]
| 10841307128625 | GSR-Lab |
| 00841307128628 | GSR-Lab |
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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.