Primary Device ID | 10841307128595 |
NIH Device Record Key | ce7a020d-44fb-425a-b52e-b89651b54051 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DIRECTguide™ Sleeve Narrow (5PK) |
Version Model Number | GSN-Lab |
Catalog Number | GSN-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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00841307128598 [Unit of Use] |
GS1 | 10841307128595 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[10841307128595]
Moist Heat or Steam Sterilization
[10841307128595]
Moist Heat or Steam Sterilization
[10841307128595]
Moist Heat or Steam Sterilization
[10841307128595]
Moist Heat or Steam Sterilization
[10841307128595]
Moist Heat or Steam Sterilization
[10841307128595]
Moist Heat or Steam Sterilization
[10841307128595]
Moist Heat or Steam Sterilization
[10841307128595]
Moist Heat or Steam Sterilization
[10841307128595]
Moist Heat or Steam Sterilization
[10841307128595]
Moist Heat or Steam Sterilization
[10841307128595]
Moist Heat or Steam Sterilization
[10841307128595]
Moist Heat or Steam Sterilization
[10841307128595]
Moist Heat or Steam Sterilization
[10841307128595]
Moist Heat or Steam Sterilization
[10841307128595]
Moist Heat or Steam Sterilization
[10841307128595]
Moist Heat or Steam Sterilization
[10841307128595]
Moist Heat or Steam Sterilization
[10841307128595]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-11-21 |
Device Publish Date | 2023-11-13 |
10841307128595 | GSN-Lab |
00841307128598 | GSN-Lab |
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 |