FDA UDI In Commercial Distribution 🇺🇸 United States

UltraSil Light Body Wash 50ml x 4

DI: D95600USLB200 · Model: US-LB200 · D.S.I DENTAL SOLUTIONS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
UltraSil Light Body Wash 50ml x 4
Primary DI
D95600USLB200
Version / Model
US-LB200
Company Name
D.S.I DENTAL SOLUTIONS LTD
Labeler DUNS
532290720
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-06-26
Public Version
2
Public Version Date
2025-02-17
Public Version Status
Update
Public Device Record Key
bf7da2c2-271f-4310-96d9-44b2dd97b811

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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ELW Material, Impression

GMDN Terms

Code Name
34799 Composite dental impression material

Identifiers

Type ID
Primary D95600USLB200

Premarket Submissions

Submission Number Supplement Number
K222741 000