| Primary Device ID | 08800041353736 |
| NIH Device Record Key | 6f53892f-da61-4b1d-9f5a-0052354f2c85 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IH Multi-unit Abutment |
| Version Model Number | AIHMAR35 |
| Catalog Number | AIHMAR35 |
| Company DUNS | 688731065 |
| Company Name | sewon medix Inc. |
| 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 | true |
| 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 | +1-224-531-3099 |
| hsong@mydentall.com |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800041353736 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2019-01-23 |
| 08800041353736 | SEWON MEDIX IH Multi-unit Abutment Regular Non-Coating Bridge Set Product, Ø4.8x3.5mm |
| 08800041353729 | SEWON MEDIX IH Multi-unit Abutment Regular Non-Coating Bridge Set Product, Ø4.8x2.5mm |
| 08800041353712 | SEWON MEDIX IH Multi-unit Abutment Regular Non-Coating Bridge Set Product, Ø4.8x1.5mm |