FDA UDI In Commercial Distribution 🇺🇸 United States

Henry Schein

DI: 10304040169794 · Model: 5703319 · HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
150

Basic Information

Brand Name
Henry Schein
Primary DI
10304040169794
Version / Model
5703319
Catalog Number
5703319
Company Name
HENRY SCHEIN, INC.
Labeler DUNS
012430880
Distribution Status
In Commercial Distribution
Device Count in Pkg
150
Record Status
Published
Publish Date
2023-08-30
Public Version
1
Public Version Date
2023-09-07
Public Version Status
New
Public Device Record Key
c8362efe-dfa0-4b69-b286-5ca4b8c8aca3

Device Description

gutta percha points #15-40

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EKM GUTTA-PERCHA

GMDN Terms

Code Name
31872 Natural gutta-percha

Identifiers

Type ID
Unit of Use 00304040169797
Primary 10304040169794