AccessGUDID - DEVICE: Single Use Brush Biopsy Instrument (00816207021706)

GUDID

Device Identifier (DI) Information

Brand Name: Single Use Brush Biopsy Instrument
Version or Model: TNL-80
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TNL-80
Company Name: ENDO-THERAPEUTICS, INC.

Primary DI Number: 00816207021706
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 825239189 *Terms of Use

Device Description: WATS Biopsy Instrument for Computer Assisted 3D Analysis

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?
38834	Flexible endoscopic cytology brush, single-use	A device intended to be used in combination with a compatible flexible endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a flexible insertion portion made of a metal coil or plastic tube, whose distal end is equipped with plastic bristles for harvesting mucosal cells, e.g., during bronchoscopy. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEE	Brush, Biopsy, General & Plastic Surgery

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
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
Length: 80 Centimeter
Device Size Text, specify: Brush Diameter 1.7 mm
Device Size Text, specify: Min Channel 2.0 mm

Device Record Status

Public Device Record Key: 7e36ea48-4365-41fb-b124-36127302fbac
Public Version Date: December 19, 2022
Public Version Number: 1
DI Record Publish Date: December 09, 2022