Device
NEST-C Impactor
Manufacturer
Paonan Biotech Co.,Ltd.
Model: NSC-0200 Catalog: NSC-0200 DI: 04710281445723 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
NEST-C Impactor
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: f5c6d5a2-8402-430c-a67f-01fff636ca1d
Distribution Status: In Commercial Distribution
DUNS Number: 657397790
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: 04710281445723
Type: Primary
Issuing Agency: GS1
GMDN
Code: 32856
Name: Orthopaedic implant impactor, reusable
Definition:
A non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). This is a reusable device.
FDA Product Codes
LXH
Orthopedic Manual Surgical Instrument