AccessGUDID - DEVICE: Histoguide wire guided forceps (00816765014295)

GUDID

Device Identifier (DI) Information

Brand Name: Histoguide wire guided forceps
Version or Model: 00711660
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00711660
Company Name: US Endoscopy

Primary DI Number: 00816765014295
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use

Device Description: The Histoguide wire guided forceps are disposable flexible wire-guided forceps used to sample tissue within the gastrointestinal tract.

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?
38711	Flexible endoscopic biopsy forceps, single-use	A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of 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
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
Handling Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2.1 Millimeter
Length: 2300 Millimeter

Device Record Status

Public Device Record Key: 8d8ed056-bb02-4d4d-89a1-a8bcb1e6d4ef
Public Version Date: March 31, 2020
Public Version Number: 4
DI Record Publish Date: July 30, 2018