AccessGUDID - DEVICE: Endocervical Speculum Blue Titanium (M803030205)

GUDID

Device Identifier (DI) Information

Brand Name: Endocervical Speculum Blue Titanium
Version or Model: Endocervical Speculum Blue Titanium
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 030205
Company Name: MedGyn Products, Inc.

Primary DI Number: M803030205
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103913430 *Terms of Use

Device Description: Endocervical Speculum Blue Titanium

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
32594	Intrauterine curette, manual	A heavy, hand-held, surgical instrument with an open ring-shaped or fenestrated tip at the distal end of a long shaft that is 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 is typically made of high-grade stainless steel and can be either rigid or malleable (bendable), and have a sharp or blunt scraping tip which is available in various shapes and sizes; it has a handle at the proximal end. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOH	Instrument, Manual, General Obstetric-Gynecologic

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: 1d5e0f70-40bb-4b61-954e-17a5777ff911
Public Version Date: June 29, 2026
Public Version Number: 2
DI Record Publish Date: November 16, 2025