Device
5MM DIA, 32CM, NEEDLE HOLDER STRAIGHT CROSS SERRATED TUNGSTEN CARBIDE JAW, SCISSOR STYLE RING AXIAL HANDLE W/ RATCHET & FLUSHPORT, 12-1/2" WORKING LENGTH
Manufacturer
ELMED INCORPORATED
ELMED INCORPORATED
Model: 52505-45LL
Catalog: 52505-45LL
DI: 00198506090332
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
5MM DIA, 32CM, NEEDLE HOLDER STRAIGHT CROSS SERRATED TUNGSTEN CARBIDE JAW, SCISSOR STYLE RING AXIAL HANDLE W/ RATCHET & FLUSHPORT, 12-1/2" WORKING 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:
0db18151-0bc4-4b5d-bc38-a6413262394a
Distribution Status:
In Commercial Distribution
DUNS Number:
049290364
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:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00198506090332
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
GCJ
Laparoscope, General & Plastic Surgery
Premarket Submissions
Submission Number:
K181173
Supplement Number:
000