FDA UDI In Commercial Distribution 🇺🇸 United States

RIVA LUTING

DI: DO3686509001 · Model: RIVA LUTING LQD REF 25G · SDI LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
RIVA LUTING
Primary DI
DO3686509001
Version / Model
RIVA LUTING LQD REF 25G
Catalog Number
8650900
Company Name
SDI LIMITED
Labeler DUNS
753221852
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-10-07
Public Version
3
Public Version Date
2018-07-06
Public Version Status
Update
Public Device Record Key
6c1383f1-05a4-4051-b195-fb61c989abc3

Device Characteristics

Single Use
No
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
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
EMA CEMENT, DENTAL

GMDN Terms

Code Name
16704 Glass ionomer dental cement

Identifiers

Type ID
Primary DO3686509001

Customer Contacts

Phone
+18002285166

Premarket Submissions

Submission Number Supplement Number
K040393 000

Storage Conditions

Type
Handling Environment Atmospheric Pressure
Temperature Range
5 – 25 Degrees Celsius