Device
Smith-Peterson Bone Gouge Curved 20.5 cm - 8" Blade Width 32 mm Stainless Steel
Manufacturer
SURTEX INSTRUMENTS LTD.
Model: OR-335-32 DI: 05056111345757 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 32 mm Stainless Steel
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: f3667d0f-01b2-4685-854c-cd4f292d5c9c
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: 05056111345757
Type: Primary
Issuing Agency: GS1
GMDN
Code: 12844
Name: Orthopaedic osteotome
Definition:
A chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.
FDA Product Codes
GDH
GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY