| Primary Device ID | 26974880990684 |
| NIH Device Record Key | ea29211a-583f-44f8-b3fc-e92ea1344d9e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Y-type Irrigation Set with 3-way Stopcock |
| Version Model Number | 5mm×7mm×600mm |
| Company DUNS | 705464292 |
| Company Name | Suzhou AcuVu medical technology Co., Ltd. |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06974880990680 [Primary] |
| GS1 | 26974880990684 [Package] Contains: 06974880990680 Package: [6 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 | 2023-12-26 |
| Device Publish Date | 2023-12-18 |
| 06974880991373 - Single action scissors | 2024-03-29 The single action scissors are intended for use in hysteroscopy procedures for cutting of soft tissue such as polyps from the ut |
| 06974880991380 - Biopsy forceps | 2024-03-29 The biopsy forceps are intended for use in hysteroscopy procedure to obtain tissue samples for examination of tissue from the u |
| 06974880991397 - Serrated forceps | 2024-03-29 The serrated forceps are intended for use in hysteroscopy procedure to obtain tissue samples for examination of tissue from the |
| 06974880991403 - Alligator grasper | 2024-03-29 The alligator grasper is intended to be used in hysteroscopy procedure for retrieval of foreign bodies and tissues from the uter |
| 06974880991410 - Hook grasper | 2024-03-29 The hook grasper is intended to be used in hysteroscopy procedure for retrieval of foreign bodies and tissues from the uterine |
| 06974880991366 - Portable Image Processor | 2024-03-28 The HTx2000 Portable Image Processor is mainly used to process image signal captured from the disposable hysteroscope and presen |
| 26974880990684 - Y-type Irrigation Set with 3-way Stopcock | 2023-12-26It is used to connect the water inlet and outlet of the hysteroscope for circulating perfusion. |
| 26974880990684 - Y-type Irrigation Set with 3-way Stopcock | 2023-12-26 It is used to connect the water inlet and outlet of the hysteroscope for circulating perfusion. |
| 26974880990691 - Y-type Irrigation Set | 2023-12-26 It is used to connect the water inlet and outlet of the hysteroscope for circulating perfusion. |