AccessGUDID - DEVICE: TAUT (14026704656452)

GUDID

Device Identifier (DI) Information

Brand Name: TAUT
Version or Model: IPN029601
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PI-104
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704656452
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 04026704419227

Device Description: TAUT INTRADUCERS 10/BOX 8 FRENCH X 3.5

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?
61520	Peritoneal drainage catheter	A sterile flexible tube designed for percutaneous insertion into the peritoneal space typically to drain ascites and abdominal abscesses. It may include disposable devices dedicated to catheter introduction, however it does not include any fluid collection bags/containers. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBW	CATHETER, PERITONEAL

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
Width: 0.5 Inch
Depth: 0.5 Inch
Length: 5.1 Inch

Device Record Status

Public Device Record Key: 15fdf882-661e-444e-b1a0-b2d30ed6fe32
Public Version Date: January 18, 2021
Public Version Number: 3
DI Record Publish Date: June 03, 2019