AccessGUDID - DEVICE: WomanCare Global Ipas EasyGrip® Cannula, 5mm (00853615006154)

GUDID

Device Identifier (DI) Information

Brand Name: WomanCare Global Ipas EasyGrip® Cannula, 5mm
Version or Model: SR5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WOMANCARE GLOBAL TRADING, INC.

Primary DI Number: 00853615006154
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064730456 *Terms of Use

Device Description: A sterile, tubular, semi-rigid, hand-held device with a permanently-integrated winged base. Each cannula has two "whistle cut" type openings and has no sharp edges. 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. Cannulae are 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:	No
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?
45254	Suction cannula, reusable	A rigid or semi-rigid, hand-held, metal or durable plastic tube designed as a conduit for the evacuation (suctioning) of blood, fluids, and other tissue debris directly from the surgical site during a surgical procedure (e.g., open-, plastic-, tissue/bone morcellation surgery). Also known as a suction tube, it is typically a general-purpose device to which the suction system tubing is connected proximally; some types may be attached to a dedicated handpiece that typically have a valve. Dedicated cannula specifically intended for a particular procedure (e.g., bronchial, dental, eye, uterine, oral, and liposuction) are also available. This is a reusable device.	Obsolete	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: Yes

Sterilization Method [?]
Liquid Chemical
High-level Disinfectant
Moist Heat or Steam Sterilization

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: 0.5mm to 1.3mm
Length: 223 Millimeter

Device Record Status

Public Device Record Key: b0cef473-04f8-4be1-a42b-3a8d34d9091b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 17, 2016