Device
PRATT RECTAL SPECULUM 85MM X 25MM, 8.5" LENGTH, STAINLESS STEEL, FIBEROPTIC & SUCTION
Manufacturer
ELMED INCORPORATED
ELMED INCORPORATED
Model: 30-37-21FS
Catalog: 30-37-21FS
DI: 00198506090370
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
PRATT RECTAL SPECULUM 85MM X 25MM, 8.5" LENGTH, STAINLESS STEEL, FIBEROPTIC & SUCTION
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:
e44ec891-1711-41db-aaee-06e2793f58ae
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:
00198506090370
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35351
Name: Rectal speculum
Definition:
A hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. It is comprised of two arms joined at a pivot point and is available in various sizes, shapes, and contours; it is usually made of stainless steel. The instrument is used for examination or for the insertion of other instrumentation. This is a reusable device.
FDA Product Codes
FFQ
Speculum, Rectal