AccessGUDID - DEVICE: WomanCare Global Flexible Karman Cannula, 8mm (00853615006079)

GUDID

Device Identifier (DI) Information

Brand Name: WomanCare Global Flexible Karman Cannula, 8mm
Version or Model: FC8
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WOMANCARE GLOBAL TRADING, INC.

Primary DI Number: 00853615006079
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064730456 *Terms of Use

Device Description: A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cannulae feature dots as indicators for measuring the depth of the uterus. Cannulae, regardless of size, have a number identifying the size of the cannula. The cannulae are color-coded and use adapters with the same color-coding. This is a single-use device, sealed into packaging and sterilized.

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):	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?
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
HGH	Cannula, Suction, Uterine

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
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Thickness of 0.5mm to 1.3mm
Length: 223 Millimeter

Device Record Status

Public Device Record Key: bfa67f4d-862e-4bbe-b0d1-57fcad2fa56f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 17, 2016