AccessGUDID - DEVICE: V. Mueller (10885403048944)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: GU3920
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GU3920
Company Name: STERIS CORPORATION

Primary DI Number: 10885403048944
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021599373 *Terms of Use

Device Description: BRODNY URETHOGRAPHIC CLAMP AND CANNULA, RUBBER ACORN TIP, SMALL METAL TIP, CANNULA OVERALL LENGTH 8-1/4" (21CM)

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:	No
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?
62163	Intrauterine cannula, reusable	A semi-rigid or rigid, plastic tube designed to be inserted into the uterus and connected to an aspirator/suction system pump to aspirate fluid/material from the uterus for treatment of incomplete abortion, first trimester abortion, and/or for menstrual regulation; it may also be intended for endometrial biopsy. This is a reusable device after appropriate sterilization/disinfection.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGI	CATHETER, URETHROGRAPHIC, MALE

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: e292d026-1c29-4548-b213-005960f2634f
Public Version Date: May 24, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2016