AccessGUDID - DEVICE: MedGyn Pipette II (M803022734)

GUDID

Device Identifier (DI) Information

Brand Name: MedGyn Pipette II
Version or Model: MedGyn Pipette II 3.1mm O.D.
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 022734
Company Name: MedGyn Products, Inc.

Primary DI Number: M803022734
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103913430 *Terms of Use

Device Description: MedGyn Pipette II 3.1mm O.D.

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?
32634	Endometrial cytology brush	A device with bristle-like projections designed to remove samples of the endometrium (the mucosal lining of the uterus) by brushing its interior surface. It is used in the study of endometrial cytology (cells). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HHI	System, Abortion, Vacuum

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: 6d4e1499-2761-40f3-8269-8a29e32dc3a9
Public Version Date: June 29, 2026
Public Version Number: 2
DI Record Publish Date: December 14, 2020