Device
Angle Handpiece
Manufacturer
Saeshin Precision Co., Ltd.
Model: CSH11XX DI: 08809260472877 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: No
First Published: 2026-05-07 Current Version: 2026-05-15
Description
Angle Handpiece
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: 99ddba46-7f9d-49a0-a604-7b4939202212
Distribution Status: In Commercial Distribution
DUNS Number: 688019566
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: No
Serial Number Tracked: Yes
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 08809260472877
Type: Primary
Issuing Agency: GS1
GMDN
Code: 45147
Name: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Definition:
A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.
FDA Product Codes
EJB
Handle, Instrument, Dental