Model: ORG-277
DI: 00810189451629
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-16
Current Version: 2026-05-25
Description
Premium Pederson Vaginal Speculum, Medium
Sterilization
Item #1:
Ethylene Oxide
Item #2:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
989ac0dc-d3d2-4309-aeed-11684baab2a0
Distribution Status:
In Commercial Distribution
DUNS Number:
112617522
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:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00810189451629
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
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Storage Handling - Storage Handling Low - @attributes - Value:
68
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Storage Handling - Storage Handling High - @attributes - Value:
72
Storage Handling - Storage Handling Type:
Storage Environment Temperature