| Primary Device ID | 10815634021317 |
| NIH Device Record Key | 8000d6b8-b8fd-4391-8591-d3a9acb74676 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HC Biologics |
| Version Model Number | HC-OPM100 |
| Company DUNS | 066839630 |
| Company Name | MICROMEDICS, 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815634021310 [Primary] |
| GS1 | 10815634021317 [Package] Contains: 00815634021310 Package: Inner Pack [5 Units] In Commercial Distribution |
| GS1 | 20815634021314 [Package] Package: Case [5 Units] In Commercial Distribution |
| FMF | Syringe, Piston |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-24 |
| Device Publish Date | 2021-08-16 |
| 10815634021768 - Fibrijet | 2024-06-26 Endoscopic Catheter Introducer |
| 00815634020788 - Biomet Biologics | 2023-12-13 Biomet Biologics Regulator |
| 10815634021089 - Nordson Medical | 2023-06-14 MALLEABLE APPLICATOR TIP, STERILE, 0.160in OD x 5.51in L |
| 00815634021358 - Pramand | 2023-05-19 Air Assisted Sprayer |
| 10815634021782 - FibriJet | 2023-03-29 FIBRIJET REGULATOR |
| 30815634021472 - FibriJet | 2023-03-08 Case 250 (bulk) individually pouched AMS600 devices corresponding to pouch UDI-DI 00815634021471 |
| 30815634021519 - FibriJet | 2023-03-08 MAGELLAN SPRAY TIP, DUAL SPRAY, BULK STERILE, Case of 250, corresponding to individual pouched AMS700 UDI-DI of 00815634021518 |
| 10815634021065 - Nordson Medical | 2022-11-14 Gasless Applicator 40CM, OUS - Baxter |