FDA UDI In Commercial Distribution 🇺🇸 United States

Henry Schein

DI: 00304040002704 · Model: 1127169 · HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50

Basic Information

Brand Name
Henry Schein
Primary DI
00304040002704
Version / Model
1127169
Catalog Number
1127169
Company Name
HENRY SCHEIN, INC.
Labeler DUNS
012430880
Distribution Status
In Commercial Distribution
Device Count in Pkg
50
Record Status
Published
Publish Date
2016-09-24
Public Version
3
Public Version Date
2019-02-07
Public Version Status
Update
Public Device Record Key
81051a8f-9ae6-485d-b3d1-b88469e9ba80

Device Description

Acclean Fluoride Varnish

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
No
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
LBH VARNISH, CAVITY

GMDN Terms

Code Name
45232 Dental coating, tooth-desensitizing

Identifiers

Type ID
Package 10304040002701
Primary 00304040002704
Unit of Use 20304040002708