Primary Device ID | 00841307130287 |
NIH Device Record Key | dd19f65e-7195-4e9b-83a2-72aa5b0eef73 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ball Abutment Housing |
Version Model Number | 1000-81 |
Catalog Number | 1000-81 |
Company DUNS | 868856969 |
Company Name | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
Device Count | 2 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00841307130287 [Unit of Use] |
GS1 | 10841307130284 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00841307130287]
Moist Heat or Steam Sterilization
[00841307130287]
Moist Heat or Steam Sterilization
[00841307130287]
Moist Heat or Steam Sterilization
[00841307130287]
Moist Heat or Steam Sterilization
[00841307130287]
Moist Heat or Steam Sterilization
[00841307130287]
Moist Heat or Steam Sterilization
[00841307130287]
Moist Heat or Steam Sterilization
[00841307130287]
Moist Heat or Steam Sterilization
[00841307130287]
Moist Heat or Steam Sterilization
[00841307130287]
Moist Heat or Steam Sterilization
[00841307130287]
Moist Heat or Steam Sterilization
[00841307130287]
Moist Heat or Steam Sterilization
[00841307130287]
Moist Heat or Steam Sterilization
[00841307130287]
Moist Heat or Steam Sterilization
[00841307130287]
Moist Heat or Steam Sterilization
[00841307130287]
Moist Heat or Steam Sterilization
[00841307130287]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-03-20 |
Device Publish Date | 2024-03-12 |
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 |