FDA UDI In Commercial Distribution 🇺🇸 United States

Henry Schein

DI: H65810053101 · Model: 1005310 · HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100

Basic Information

Brand Name
Henry Schein
Primary DI
H65810053101
Version / Model
1005310
Catalog Number
1005310
Company Name
HENRY SCHEIN, INC.
Labeler DUNS
012430880
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2020-09-17
Public Version
1
Public Version Date
2020-09-25
Public Version Status
New
Public Device Record Key
b13ff916-3b71-424f-b3dd-70ba78aa8e70

Device Description

Gutta Percha Points 30mm

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
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
34791 Root canal obturating point

Identifiers

Type ID
Unit of Use H65810053109
Primary H65810053101