| Primary Device ID | 08800041351923 |
| NIH Device Record Key | 244838c2-bb7d-42f5-b4d2-5ef53a90bb68 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IH Pick-up Impression Coping |
| Version Model Number | AIHPIRH4515 |
| Catalog Number | AIHPIRH4515 |
| 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@mydental.com |
| Stent Diameter | 4.8 Millimeter |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800041351923 [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 | 2019-09-10 |
| 08800041351923 | SEWON MEDIX IH Pick-up Impression Coping Regular Body Hex Set Product, Ø4.5x17.5x6.5mm |
| 08800041351916 | SEWON MEDIX IH Pick-up Impression Coping Regular Body Hex Set Product, Ø4.5x13.5x5.5mm |
| 08800041351862 | SEWON MEDIX IH Pick-up Impression Coping Mini Body Hex Set Product, Ø4.0x17.6x6.6mm |
| 08800041351855 | SEWON MEDIX IH Pick-up Impression Coping Mini Body Hex Set Product, Ø4.0x13.6x5.6mm |