Device
INSULATED STANDARD GRAVES VAGINAL SPECULUM, CLOSED SIDE, MEDIUM BLADE, 4" X 1-3/8"
Manufacturer
ELMED INCORPORATED
ELMED INCORPORATED
Model: STE321002I
Catalog: STE321002I
DI: 00198506090325
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
INSULATED STANDARD GRAVES VAGINAL SPECULUM, CLOSED SIDE, MEDIUM BLADE, 4" X 1-3/8"
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f02e664d-4047-48fd-9563-eb487b940a44
Distribution Status:
In Commercial Distribution
DUNS Number:
049290364
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00198506090325
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35352
Name: Vaginal speculum, reusable
Definition:
A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. This is a reusable device.
FDA Product Codes
HDF
Speculum, Vaginal, Metal