| Primary Device ID | E0HM50357361 |
| NIH Device Record Key | 10d91626-f87b-4680-bda0-4ff1450fba2b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | infinity OCTAGON TL RP Healing abutment GH 3.0 mm |
| Version Model Number | 5035736 |
| Catalog Number | 5035736 |
| Company DUNS | 318034329 |
| Company Name | Hager & Meisinger Gesellschaft mit beschränkter Haftung |
| 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 | 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(508)588-3100 |
| kathystrange@acesurgical.com | |
| Phone | +1(508)588-3100 |
| kathystrange@acesurgical.com | |
| Phone | +1(508)588-3100 |
| kathystrange@acesurgical.com | |
| Phone | +1(508)588-3100 |
| kathystrange@acesurgical.com | |
| Phone | +1(508)588-3100 |
| kathystrange@acesurgical.com | |
| Phone | +1(508)588-3100 |
| kathystrange@acesurgical.com | |
| Phone | +1(508)588-3100 |
| kathystrange@acesurgical.com | |
| Phone | +1(508)588-3100 |
| kathystrange@acesurgical.com | |
| Phone | +1(508)588-3100 |
| kathystrange@acesurgical.com | |
| Phone | +1(508)588-3100 |
| kathystrange@acesurgical.com | |
| Phone | +1(508)588-3100 |
| kathystrange@acesurgical.com | |
| Phone | +1(508)588-3100 |
| kathystrange@acesurgical.com | |
| Phone | +1(508)588-3100 |
| kathystrange@acesurgical.com | |
| Phone | +1(508)588-3100 |
| kathystrange@acesurgical.com | |
| Phone | +1(508)588-3100 |
| kathystrange@acesurgical.com | |
| Phone | +1(508)588-3100 |
| kathystrange@acesurgical.com | |
| Phone | +1(508)588-3100 |
| kathystrange@acesurgical.com | |
| Phone | +1(508)588-3100 |
| kathystrange@acesurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E0HM50357361 [Primary] |
| HIBCC | E0HM50357369 [Previous] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[E0HM50357361]
Moist Heat or Steam Sterilization
[E0HM50357361]
Moist Heat or Steam Sterilization
[E0HM50357361]
Moist Heat or Steam Sterilization
[E0HM50357361]
Moist Heat or Steam Sterilization
[E0HM50357361]
Moist Heat or Steam Sterilization
[E0HM50357361]
Moist Heat or Steam Sterilization
[E0HM50357361]
Moist Heat or Steam Sterilization
[E0HM50357361]
Moist Heat or Steam Sterilization
[E0HM50357361]
Moist Heat or Steam Sterilization
[E0HM50357361]
Moist Heat or Steam Sterilization
[E0HM50357361]
Moist Heat or Steam Sterilization
[E0HM50357361]
Moist Heat or Steam Sterilization
[E0HM50357361]
Moist Heat or Steam Sterilization
[E0HM50357361]
Moist Heat or Steam Sterilization
[E0HM50357361]
Moist Heat or Steam Sterilization
[E0HM50357361]
Moist Heat or Steam Sterilization
[E0HM50357361]
Moist Heat or Steam Sterilization
[E0HM50357361]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-14 |
| Device Publish Date | 2017-02-13 |
| E0HM266735268BE00101 - n/a | 2025-07-21 Sterile Cabide Round ,1,0 FG |
| E0HM266736230BE00101 - n/a | 2025-07-21 Sterile Cabide Round ,2,3 FG |
| E0HM266736285BE00101 - n/a | 2025-07-21 Sterile Cabide Round ,1,0 RA |
| E0HM266736338BE00101 - n/a | 2025-07-21 Sterile Cabide Round ,1,8 RA |
| E0HM266736383BE00101 - n/a | 2025-07-21 Sterile Cabide Round ,2,3 RA |
| E0HM39310540000001 - Bone Management | 2025-07-21 Screwdriver RA extra short |
| E0HM39MSTDW1 - Bone Management | 2025-07-21 Screwdriver RA |
| E0HM740SSA011 - n/a | 2025-07-21 Mini-invasive extraction & SSA kit by Dr Gary Finelle & Pr France Lambert |