| Primary Device ID | 08800041353095 |
| NIH Device Record Key | e2b01cf2-e184-4dc9-9b8a-bdb7b614a601 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IH Fixture Lab Analog |
| Version Model Number | IHFLAR120D |
| Catalog Number | IHFLAR120D |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800041353095 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-21 |
| Device Publish Date | 2020-12-11 |
| 08800041365098 - XP-I SLA Fixture | 2022-02-24 SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x8.5mm |
| 08800041365104 - XP-I SLA Fixture | 2022-02-24 SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x10.0mm |
| 08800041365111 - XP-I SLA Fixture | 2022-02-24 SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x11.5mm |
| 08800041365128 - XP-I SLA Fixture | 2022-02-24 SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x13.0mm |
| 08800041365135 - XP-I SLA Fixture | 2022-02-24 SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x15.0mm |
| 08800041365142 - XP-I SLA Fixture | 2022-02-24 SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø3.5x7.0mm |
| 08800041365159 - XP-I SLA Fixture | 2022-02-24 SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø3.5x8.5mm |
| 08800041365166 - XP-I SLA Fixture | 2022-02-24 SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø3.5x10.0mm |