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 |
26974880991421 - HTx Procedure Pack | 2024-07-08 The procedure pack is an accessory kit of the HTx disposable hysteroscope system, which contains an inflow tubing, a drainage fl |
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 | 2023-12-26 It is used to connect the water inlet and outlet of the hysteroscope for circulating perfusion. |