biopsy forceps

Basic Information

• Brand Name: biopsy forceps
• Primary DI: 06974880990246
• Version / Model: RSI-340-5-C
• 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: 7cd038f4-c8c9-4aa7-acc6-1afdb9fa4c48

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): No
• 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
35732	Rigid endoscopic biopsy forceps, reusable	A rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974880990246	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