| Primary Device ID | EAMIAFC1000 |
| NIH Device Record Key | fba0548c-9f1f-4f07-9d12-c189a721d334 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | A.M.I. FasciaCutter Disposable Instrument |
| Version Model Number | AFC 100 |
| Catalog Number | AFC 100 |
| Company DUNS | 303655286 |
| Company Name | AMI Agency for Medical Innovations GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| EAMIMCS55110 - More-Cell-System | 2021-12-17 More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery t |
| EAMIMCS55311 - More-Cell Bag | 2021-12-17 More-Cell Bag is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to e |
| MCS55511 - More-Cell-System 30 | 2021-12-17 More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgeryto |
| EAMIAFC1000 - A.M.I. FasciaCutter Disposable Instrument | 2020-02-06The A.M.I. FasciaCutter Disposable Instrument is a sterile, disposable scalpel that is used to for enlargement of trocar incisions. The instrument is used in conjunction with
an A.M.I. TissueBag for retrieval of specimen bags. The A.M.I. Fascia Cutter Disposable Instrument allows for easy removal of specimens in order to avoid risk of damaging the specimen bag while enlarging the trocar incision. |
| EAMIAFC1000 - A.M.I. FasciaCutter Disposable Instrument | 2020-02-06 The A.M.I. FasciaCutter Disposable Instrument is a sterile, disposable scalpel that is used to for enlargement of trocar incisio |
| EAMIA054920 - A.M.I.-dock Applicator Short 5mm | 2019-04-23 Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 5mm.
The A.M.I.-dock Applicator serves as endoscopic m |
| EAMIA054930 - A.M.I.-dock Applicator Curved 5mm | 2019-04-23 Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 5mm.
The A.M.I.-dock Applicator serves as endoscopic c |
| EAMIA101110 - A.M.I.-dock Applicator Standard 10mm | 2019-04-23 Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 10mm.
The A.M.I.-dock Applicator serves as endoscopic |
| EAMIA101120 - A.M.I.-dock Applicator Short 10mm | 2019-04-23 Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 10mm.
The A.M.I.-dock Applicator serves as endoscopic |