AccessGUDID - DEVICE: SteriGear (00618125155453)

GUDID

Device Identifier (DI) Information

Brand Name: SteriGear
Version or Model: 27300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10119
Company Name: TIDI PRODUCTS, LLC

Primary DI Number: 00618125155453
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 063519193 *Terms of Use
Previous DI: 01618125155452

Device Description: Drain Bag with Hose

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):	No
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?
61677	Urological fluid funnel	A 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.	Active	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: deaf2477-ee03-4455-9e40-07fe35f9e5ea
Public Version Date: March 22, 2024
Public Version Number: 3
DI Record Publish Date: September 27, 2022