FDA UDI In Commercial Distribution 🇺🇸 United States

Henry Schein

DI: H65820203151 · Model: 2020315 · HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20

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Basic Information

Brand Name
Henry Schein
Primary DI
H65820203151
Version / Model
2020315
Catalog Number
2020315
Company Name
HENRY SCHEIN, INC.
Labeler DUNS
012430880
Distribution Status
In Commercial Distribution
Device Count in Pkg
20
Record Status
Published
Publish Date
2020-06-18
Public Version
1
Public Version Date
2020-06-26
Public Version Status
New
Public Device Record Key
217adfed-2c81-494d-a2e7-e6fc611a104a

Device Description

OBTURATOR - OBT20 - SIZE 20 Obt 20pk CHC1

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
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EKM GUTTA-PERCHA

GMDN Terms

Code Name
47751 Warm-bonded endodontic obturation system obturator

Identifiers

Type ID
Unit of Use H65820203159
Primary H65820203151