Device
4x10mm Pituitary Rongeur, Serrated Teeth, 30° Upward Angled
Manufacturer
PACIFIC INSTRUMENTS, INC.
PACIFIC INSTRUMENTS, INC.
Model: PI-3911
DI: 00810168190389
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
4x10mm Pituitary Rongeur, Serrated Teeth, 30° Upward Angled
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:
7ed9c16d-1a13-4364-a064-d8ec3d543465
Distribution Status:
In Commercial Distribution
DUNS Number:
621872006
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:
00810168190389
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35541
Name: Spinal rongeur
Definition:
A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.
FDA Product Codes
HTX
Rongeur