hook grasper

Basic Information

• Brand Name: hook grasper
• Primary DI: 06974880990604
• Version / Model: RSI-340-5-G
• 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: 2023-05-01
• Public Version: 1
• Public Version Date: 2023-05-09
• Public Version Status: New
• Public Device Record Key: 09f54e5a-d975-4457-8c36-64c9e41599d6

Device Description

Hysteroscopic surgical instruments are used for the removal of uterine lesions; the surgical instruments range from 1.66mm, 2.0mm and 2.3mm outside diameter; they are suitable for 5Fr, 6Fr and 7Fr hysteroscopes with working channel.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
35080	Rigid endoscopic tissue manipulation forceps, reusable	A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974880990604	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Atherectomy Cutter Diameter	1.66	Millimeter
Atherectomy Cutter Diameter	2	Millimeter
Atherectomy Cutter Diameter	2.3	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 45 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: – 85 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: – 80 Percent (%) Relative Humidity