FDA UDI In Commercial Distribution 🇺🇸 United States

Henry Schein

DI: 00304040107850 · Model: 5701372 · HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5

Basic Information

Brand Name
Henry Schein
Primary DI
00304040107850
Version / Model
5701372
Catalog Number
5701372
Company Name
HENRY SCHEIN, INC.
Labeler DUNS
012430880
Distribution Status
In Commercial Distribution
Device Count in Pkg
5
Record Status
Published
Publish Date
2019-04-26
Public Version
1
Public Version Date
2019-05-06
Public Version Status
New
Public Device Record Key
b4ec0c64-ef18-4ef3-94a3-6986d3737dc6

Device Description

Titanium Post Introductory Kit. 4 x yellow size 0 titanium posts, 4 x red size 1 titanium posts, 4 x blue size 2 titanium posts; 1 x yellow size 0 primary reamer, 1 x red size 1 primary reamer, 1 x blue size 2 primary reamer; 1 x yellow size 0 secondary drill, 1 x red size 1 secondary drill, 1 x blue size 2 secondary drill; 1 x extender; 1 x internal wrench, 1 x external wrench; 1 x gauge card.

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
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ELR POST, ROOT CANAL

GMDN Terms

Code Name
38609 Root canal post, preformed

Identifiers

Type ID
Primary 00304040107850
Unit of Use 10304040107857