AccessGUDID - DEVICE: Totalis™ Rigid Endo Kit (00801741097577)

GUDID

Device Identifier (DI) Information

Brand Name: Totalis™ Rigid Endo Kit
Version or Model: REK24N
Commercial Distribution Status: In Commercial Distribution
Catalog Number: REK24N
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741097577
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Totalis™ Rigid Endo Kit with InLay® Ureteral Stent, EcoFlex™ Stone Basket and NiCore® Nitinol Guidewire

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:	Yes
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?
61177	Ureteral patency kit	A collection of devices intended to assist treatment of a blocked ureter and to help maintain ureteral patency through natural orifice or percutaneous access. It includes a polymeric ureteral stent, a device(s) intended to trap, retrieve, and/or manipulate urinary stones (e.g., urinary stone retrieval basket), and typically devices associated with access/stent-implantation (e.g., guidewire). This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FAD	STENT, URETERAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 24 Centimeter
Catheter Gauge: 6 French

Device Record Status

Public Device Record Key: bac42079-601a-4ed6-9115-d461221ec8eb
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 14, 2015