Device
5mm Double Action Spoon Forcep, Ratcheting Handle with Rotation, Bariatric Length
Manufacturer
Endoplus
Endoplus
Model: E382RR-45
DI: 00817401029154
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Description
5mm Double Action Spoon Forcep, Ratcheting Handle with Rotation, Bariatric Length
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:
b74bcd6e-75b0-4b48-bc01-c0e35cdb9d6a
Distribution Status:
In Commercial Distribution
DUNS Number:
794679167
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
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:
00817401029154
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35080
Name: Rigid endoscopic tissue manipulation forceps, reusable
Definition:
A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.
FDA Product Codes
HET
Laparoscope, Gynecologic (And Accessories)
Premarket Submissions
Submission Number:
K925079
Supplement Number:
000