Disposable Sterile Drape

GUDID 06974880990673

Disposable sterile drape protects the image cable from contamination by dilating fluid running down the HTx disposable hysteroscope.

Suzhou AcuVu medical technology Co., Ltd.

Medical equipment drape, single-use

Primary Device ID	06974880990673
NIH Device Record Key	0d2f77e6-c4ed-44f0-ad8a-31fc5a0fee78
Commercial Distribution Status	In Commercial Distribution
Brand Name	Disposable Sterile Drape
Version Model Number	1.5m×15.2cm
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

Customer Support Contacts

Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com
Phone	6178344997
Email	frank.huang@sz-acuvu.com

Operating and Storage Conditions

Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974880990673 [Primary]
GS1	26974880990677 [Package] Package: [50 Units] In Commercial Distribution

FDA Product Code

NWW	Hysteroscope Accessories

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-09-18
Device Publish Date	2023-09-08

Devices Manufactured by Suzhou AcuVu medical technology Co., Ltd.

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.