Device
Special Instrument, Oscillating Rasp, Flat Single-sided
Manufacturer
Paragon 28, Inc.
Paragon 28, Inc.
Model: SP99-RSP-1001
Catalog: SP99-RSP-1001
DI: 00889795155689
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
Special Instrument, Oscillating Rasp, Flat Single-sided
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2f24c057-6ca4-45f1-be13-76e45a0349b5
Distribution Status:
In Commercial Distribution
DUNS Number:
042961576
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00889795155689
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46476
Name: Surgical saw blade, oscillating, single-use
Definition:
A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at its distal end to cut in a rapid oscillating (circular/arc-shaped) motion; it is not intended to perform a sagittal motion. This is a single-use device.
FDA Product Codes
HTR
RASP