AccessGUDID - DEVICE: MedGyn Uterine Curette (M803022112)

GUDID

Device Identifier (DI) Information

Brand Name: MedGyn Uterine Curette
Version or Model: 12 mm rigid curved curette
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 022112
Company Name: MEDGYN PRODUCTS, INC.

Primary DI Number: M803022112
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103913430 *Terms of Use

Device Description: 12 mm rigid curved curette

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	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?
32655	Intrauterine cannula, single-use	A sterile, semi-rigid or rigid, plastic or, less frequently metal, tube designed for insertion into the uterus. It is frequently connected directly or through an external tube or catheter to an irrigator and/or aspirator for irrigation, infusion, or withdrawal of substances. It may also provide a port through which instruments and/or probes are passed to perform a variety of gynaecologic/obstetric diagnostic, therapeutic, and surgical procedures. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCY	Curette, Uterine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 60589dc6-b3a4-4a3b-b3f3-85e2ddaa9c17
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 07, 2016