AccessGUDID - DEVICE: Hern Dilator (M803030815)

GUDID

Device Identifier (DI) Information

Brand Name: Hern Dilator
Version or Model: Hern Dilator 65Fr (21.6 mm)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 030815
Company Name: MedGyn Products, Inc.

Primary DI Number: M803030815
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103913430 *Terms of Use

Device Description: Hern Dilator 65Fr (21.6 mm)

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?
11266	Fixed-diameter cervical dilator, reusable	A rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have one diameter or two different size diameters, one at each end of the instrument. The device is typically available in a set of graduated sizes that are applied in succession. It is used to allow the passage of a curette or other instruments into the uterus and/or enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HDQ	Dilator, Cervical, Fixed Size

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: 1635c6ff-1b5c-4be3-b92b-5dcdf7056c5f
Public Version Date: June 29, 2026
Public Version Number: 2
DI Record Publish Date: April 16, 2025