Device
UltraCut TC Fomon Nasal Rasp Fig. 1 - 2 20.5 cm - 8" Cutting Edge 30 x 8 mm Stainless Steel
Manufacturer
SURTEX INSTRUMENTS LTD.
SURTEX INSTRUMENTS LTD.
Model: RH-746-01
DI: 05055445973421
Status: New
MRI: MR Conditional
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
UltraCut TC Fomon Nasal Rasp Fig. 1 - 2 20.5 cm - 8" Cutting Edge 30 x 8 mm Stainless Steel
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b3ed07ba-6831-4654-84e3-502f1622e85c
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:
05055445973421
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35559
Name: Bone file/rasp, manual, reusable
Definition:
A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.
FDA Product Codes
GAC
RASP, SURGICAL, GENERAL & PLASTIC SURGERY