AccessGUDID - DEVICE: Single use biopsy forceps PGB (06971176281521)

GUDID

Device Identifier (DI) Information

Brand Name: Single use biopsy forceps PGB
Version or Model: PGB
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Zhuhai Pusen Medical Technology Co, Ltd

Primary DI Number: 06971176281521
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544427443 *Terms of Use

Device Description: The single use biopsy forceps is intended to be used through working channel of endoscope to remove tissue samples.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
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?
33199	Flexible endoscopic tissue manipulation forceps, single-use	A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3e9b458c-02b4-43dd-9ea9-fcea21ca3fd1
Public Version Date: February 19, 2025
Public Version Number: 1
DI Record Publish Date: February 11, 2025