| Primary Device ID | E0HM5048101 |
| NIH Device Record Key | f4dd8bc0-f2cf-4146-8bf0-845e849beb52 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | infinity OCTAGON |
| Version Model Number | 504810 |
| Catalog Number | 504810 |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E0HM5048101 [Primary] |
| HIBCC | XXXX5048109 [Previous] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-14 |
| Device Publish Date | 2015-08-30 |
| E0HM504814BL1 | Bone Level Implant Regular Connect Ø4.8x14 |
| E0HM5048141 | Tissue Level Implant Regular Platform Ø4,8x14 |
| E0HM504812WP1 | Tissue Level Implant Wide Platform Ø4,8x8 |
| E0HM504812BL1 | Bone Level Implant Regular Connect Ø4.8x12 |
| E0HM5048121 | Tissue Level Implant Regular Platform Ø4,8x12 |
| E0HM504810WP1 | Tissue Level Implant Wide Platform Ø4,8x10 |
| E0HM504810BL1 | Bone Level Implant Regular Connect Ø4.8x10 |
| E0HM5048101 | Tissue Level Implant Regular Platform Ø4,8x10 |
| E0HM504808WP1 | Tissue Level Implant Wide Platform Ø4,8x8 |
| E0HM504808BL1 | Bone Level Implant Regular Connect Ø4.8x8 |
| E0HM5048081 | Tissue Level Implant Regular Platform Ø4,8x8 |
| E0HM504114BL1 | Bone Level Implant Regular Connect Ø4.1x14 |
| E0HM5041141 | Tissue Level Implant Regular Platform Ø4,1x14 |
| E0HM504112T1 | Tissue Level Implant Tapered Design Ø4,1x12 |
| E0HM504112BL1 | Bone Level Implant Regular Connect Ø4.1x12 |
| E0HM5041121 | Tissue Level Implant Regular Platform Ø4,1x12 |
| E0HM504110T1 | Tissue Level Implant Tapered Design Ø4,1x10 |
| E0HM504110BL1 | Bone Level Implant Regular Connect Ø4.1x10 |
| E0HM5041101 | Tissue Level Implant Regular Platform Ø4,1x10 |
| E0HM504108BL1 | Bone Level Implant Regular Connect Ø4.1x8 |
| E0HM5041081 | Tissue Level Implant Regular Platform Ø4,1x8 |
| E0HM503314BL1 | Bone Level Implant Narrow Connect Ø3.3x14 |
| E0HM5033141 | Tissue Level Implant Regular Platform Ø3,3x14 |
| E0HM503312BL1 | Bone Level Implant Narrow Connect Ø3.3x12 |
| E0HM5033121 | Tissue Level Implant Regular Platform Ø3,3x12 |
| E0HM503310BL1 | Bone Level Implant Narrow Connect Ø3.3x10 |
| E0HM5033101 | Tissue Level Implant Regular Platform Ø3,3x10 |
| E0HM503308BL1 | Bone Level Implant Narrow Connect Ø3,3x8 |
| E0HM5033081 | Tissue Level Implant Regular Platform Ø3,3x8 |