AccessGUDID - DEVICE: THD BIOPSY (08051887047413)

GUDID

Device Identifier (DI) Information

Brand Name: THD BIOPSY
Version or Model: THD BIOPSY (GI - XL)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800328
Company Name: THD SPA

Primary DI Number: 08051887047413
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338430324 *Terms of Use

Device Description: THD BIOPSY are disposable rigid biopsy forceps for use with THD anoscopes and rectoscopes during various diagnostic and surgical procedures of the anal canal and/or rectum. THD BIOPSY are equipped with a rotating ring nut that allows the instrument to be rotated and oriented during the procedure, facilitating the access from different angles.

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":	Yes
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?
46228	Rigid endoscopic biopsy forceps, single-use	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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCL	Forceps, Biopsy, Non-Electric

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
Length: 34 Centimeter

Device Record Status

Public Device Record Key: 5fd32410-ee61-466f-97bc-a698e31f70b3
Public Version Date: February 28, 2025
Public Version Number: 1
DI Record Publish Date: February 20, 2025