| Primary Device ID | M648C0502001 |
| NIH Device Record Key | 2aec1ea4-4dd7-45d0-b61e-dbb879be8e18 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FLUID MANAGEMENT PACK |
| Version Model Number | C020500 |
| Company DUNS | 011560431 |
| Company Name | OBP CORPORATION |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M648C0502000 [Primary] |
| HIBCC | M648C0502001 [Package] Contains: M648C0502000 Package: BOX [5 Units] In Commercial Distribution |
| NWW | Hysteroscope Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-31 |
| Device Publish Date | 2019-10-23 |
| M648C0601002 - ANOSPEC | 2023-11-17 90mm x 18mm SINGLE-USE SLOTTED ANOSCOPE WITH BUILT-IN LIGHT SOURCE |
| M648C0601102 - ANOSPEC | 2023-11-17 96mm x 23mm SINGLE-USE SLOTTED ANOSCOPE WITH BUILT-IN LIGHT SOURCE |
| M648C0601202 - ANOSPEC | 2023-11-17 103x18mm SINGLE-USE BEVELED ANOSCOPE WITH BUILT-IN LIGHT SOURCE |
| M648C1102101 - ONETRAC LXS | 2022-04-25 ONETRAC LXS SUCTION, METAL TIP, WITH BUILT IN RADIAL LIGHT SOURCE, SINGLE USE - STERILE |
| M648C1102201 - ONETRAC LXS | 2022-04-25 ONETRAC LXS SUCTION, TAPER TIP, WITH BUILT IN RADIAL LIGHT SOURCE, SINGLE USE - STERILE |
| M648C1002801 - ONETRAC LX | 2021-06-10 Retractor 90x30mm with Built-In Single-Use Multi-LED Light Source - STERILE |
| M648C1002901 - ONETRAC LX | 2021-06-10 Retractor 135X20mm with Built-In Single-Use Multi-LED Light Source - STERILE |
| M648C1102001 - ONETRAC LXS | 2021-04-20 ONETRAC LXS SUCTION, CROWN TIP, WITH BUILT IN RADIAL LIGHT SOURCE, SINGLE USE - STERILE |