Model: 10-0021
Catalog: 10-0021
DI: 06945095543794
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
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:
a1050784-a865-4f0a-82a7-4a1a5ea6f8ce
Distribution Status:
In Commercial Distribution
DUNS Number:
421348837
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:
06945095543794
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
ELA
Instrument, Hand, Calculus Removal