AccessGUDID - DEVICE: V. Mueller (10885403044878)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: GL1740
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: GL1740
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403044878
Issuing Agency: GS1
Commercial Distribution End Date: January 07, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: V. Mueller RANDALL ENDOMETRIAL BIOPSY SUCTION CURETTE LUER LOCK HUB, OUTSIDE DIA 4MM OVERALL LENGTH 9-1/4" (23.5CM)

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?
47341	Intrauterine curette, suction	A sterile, tubular, semi-rigid, hand-held device used to scrape the lining of the uterus for the removal of tissue during a gynaecological procedure, typically for the removal of an early or non-viable embryo/foetus. The device typically has a rounded blunt nose and an opening(s) with a blunt scraping edge(s) at the distal end. It is connected at the proximal end to tubing and a suction source, typically an abortion suction system, which provides regulated suction. Also known as a pregnancy termination catheter, it is typically made of plastic and is available in various shapes and sizes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HHK	CURETTE, SUCTION, ENDOMETRIAL (AND ACCESSORIES)

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: b8c0a2a5-b30d-4c64-b1af-65c160a523d9
Public Version Date: March 07, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2016