Disposable Sterile Drape

Basic Information

• Brand Name: Disposable Sterile Drape
• Primary DI: 06974880990673
• Version / Model: 1.5m×15.2cm
• Company Name: Suzhou AcuVu medical technology Co., Ltd.
• Labeler DUNS: 705464292
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-08
• Public Version: 2
• Public Version Date: 2023-09-28
• Public Version Status: Update
• Public Device Record Key: 0d2f77e6-c4ed-44f0-ad8a-31fc5a0fee78

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	884.1690	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12535	Medical equipment drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974880990673	GS1
Package	26974880990677	GS1		10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: – 80 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius