Device
HANDLE SE SIMPLE STEM
Manufacturer
PREMIER DENTAL PRODUCTS COMPANY
Model: 1003581 DI: 00348783010190 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-04-28 Current Version: 2026-05-06
Description
HANDLE SE SIMPLE STEM
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: b2b8a8ed-9a80-4a22-98a1-efd223362de8
Distribution Status: In Commercial Distribution
DUNS Number: 014789663
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: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00348783010190
Type: Primary
Issuing Agency: GS1
GMDN
Code: 31776
Name: Dental mirror, reusable
Definition:
A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device.
FDA Product Codes
EJB
Handle, Instrument, Dental