FDA UDI In Commercial Distribution 🇺🇸 United States

Henry Schein

DI: 10304040102883 · Model: 5701284 · HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6

Basic Information

Brand Name
Henry Schein
Primary DI
10304040102883
Version / Model
5701284
Catalog Number
5701284
Company Name
HENRY SCHEIN, INC.
Labeler DUNS
012430880
Distribution Status
In Commercial Distribution
Device Count in Pkg
6
Record Status
Published
Publish Date
2019-06-20
Public Version
1
Public Version Date
2019-06-28
Public Version Status
New
Public Device Record Key
5eb3dc29-64fd-4740-84bc-3aa9a3bdd68a

Device Description

Maxima Hedstromfile 25mm #55

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
Yes
Sterilization Prior Use
Yes
Sterilization Methods
Radiation Sterilization

Product Codes

Code Name
EKS FILE, PULP CANAL, ENDODONTIC

GMDN Terms

Code Name
31878 Manual endodontic file/rasp, reusable

Identifiers

Type ID
Primary 10304040102883
Unit of Use 00304040102886