FDA UDI Not in Commercial Distribution 🇺🇸 United States

ULTRAMAT S

DI: 09336472005535 · Model: 5546057 · SDI LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
ULTRAMAT S
Primary DI
09336472005535
Version / Model
5546057
Catalog Number
5546057
Company Name
SDI LIMITED
Labeler DUNS
753221852
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-02-16
Public Version
1
Public Version Date
2026-02-24
Public Version Status
New
Public Device Record Key
7756f84a-0763-4ee8-a34b-5d11414ca1bf
Distribution End Date
2026-02-16

Device Description

ULTRAMAT S US

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EFD Amalgamator, Dental, Ac-Powered

GMDN Terms

Code Name
10082 Dental amalgam mixer

Identifiers

Type ID
Primary 09336472005535