| Primary Device ID | 26974880990691 |
| NIH Device Record Key | 283055e2-264e-4696-8f50-ee5663b74b9a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Y-type Irrigation Set |
| 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 | 06974880990697 [Primary] |
| GS1 | 26974880990691 [Package] Contains: 06974880990697 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 |
| 26974880991445 - HTx Disposable Hysteroscope | 2025-05-16 Disposable hysteroscope with a working channel suitable for 9Fr tools to cut and remove uterine lesions. The outer diameter of t |
| 26974880991452 - HTx Disposable Hysteroscope | 2025-05-16 Disposable hysteroscope with a working channel suitable for 9Fr tools to cut and remove uterine lesions. The outer diameter of t |
| 06974880991632 - HTx Disposable Hysteroscope | 2025-05-16 Disposable hysteroscope with a working channel suitable for 9Fr tools to cut and remove uterine lesions. The outer diameter of t |
| 16974880993121 - Single action scissors | 2025-05-16 The single action scissors are intended for use in hysteroscopy procedures for cutting of soft tissue such as polyps from the ut |
| 16974880993138 - Biopsy forceps | 2025-05-16 The biopsy forceps are intended for use in hysteroscopy procedure to obtain tissue samples for examination of tissue from the u |
| 16974880993145 - Serrated forceps | 2025-05-16 The serrated forceps are intended for use in hysteroscopy procedure to obtain tissue samples for examination of tissue from the |
| 16974880993152 - Alligator grasper | 2025-05-16 The alligator grasper is intended to be used in hysteroscopy procedure for retrieval of foreign bodies and tissues from the uter |
| 16974880993169 - Hook grasper | 2025-05-16 The hook grasper is intended to be used in hysteroscopy procedure for retrieval of foreign bodies and tissues from the uterine |