Device
Smith-Peterson Bone Gouge Curved 20.5 cm - 8" Blade Width 9 mm Stainless Steel
Manufacturer
SURTEX INSTRUMENTS LTD.
Model: OR-335-09 DI: 05055445939441 Status: New MRI: MR Conditional Single-use: No Rx: No OTC: No
First Published: 2026-05-12 Current Version: 2026-05-20
Description
Smith-Peterson Bone Gouge Curved 20.5 cm - 8" Blade Width 9 mm Stainless Steel
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 67e383ba-4f7b-4d99-949d-6f6a5da4e6a2
Distribution Status: In Commercial Distribution
DUNS Number: 216232502
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: No
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: 05055445939441
Type: Primary
Issuing Agency: GS1
GMDN
Code: 35090
Name: Surgical gouge
Definition:
A heavy-duty, hand-held, surgical instrument used to remove pieces of bone or other hard tissue during orthopaedic and plastic surgery procedures. It typically comprises a handle proximally which becomes a shaft that terminates in a convex profile with a sharp, semi-lunar, bevelled cutting edge to facilitate tissue removal. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. It is typically made of high-grade stainless steel and can be designed as a one-piece instrument (all steel) or the handle may be made of synthetic material (e.g., Tufnol). This is a reusable device.
FDA Product Codes
GDH
GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY