AccessGUDID - DEVICE: Precision Surgical (00618125167906)

GUDID

Device Identifier (DI) Information

Brand Name: Precision Surgical
Version or Model: 26676
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 26676
Company Name: TIDI PRODUCTS, LLC

Primary DI Number: 00618125167906
Issuing Agency: GS1
Commercial Distribution End Date: November 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 063519193 *Terms of Use
Previous DI: 01618125167905

Device Description: Precision Surgical Urology Drain Bags Vinyl Sterile Fits Hoop Style Urology Frames 20 per Case

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?
61676	Urological fluid funnel, sterile	A sterile device designed to be attached to a urological operating table (e.g., to a hoop frame) to channel fluids associated with a urological examination or surgery (i.e., body and irrigation fluids) from the table to an appropriate container, surgical suction system, or floor drain. It is typically constructed of flexible plastic material in the shape of funnel; it may include a filter, to trap tissue debris (e.g., urinary stones), and tubing. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MMZ	Table, Cystometric, 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
No Device Sizes

Device Record Status

Public Device Record Key: ed26a500-30b0-40ea-8b09-5f4dff03e202
Public Version Date: December 01, 2023
Public Version Number: 3
DI Record Publish Date: September 26, 2022