AccessGUDID - DEVICE: biopsy forceps (06974880990246)

GUDID

Device Identifier (DI) Information

Brand Name: biopsy forceps
Version or Model: RSI-340-5-C
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Suzhou AcuVu medical technology Co., Ltd.

Primary DI Number: 06974880990246
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 705464292 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NWW	Hysteroscope Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 10 and 45 Degrees Celsius
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity
Storage Environment Humidity: less than 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Atherectomy Cutter Diameter: 1.66 Millimeter
Atherectomy Cutter Diameter: 2 Millimeter
Atherectomy Cutter Diameter: 2.3 Millimeter

Device Record Status

Public Device Record Key: 7cd038f4-c8c9-4aa7-acc6-1afdb9fa4c48
Public Version Date: May 09, 2023
Public Version Number: 1
DI Record Publish Date: May 01, 2023