FDA UDI In Commercial Distribution 🇺🇸 United States

Precisil Monophase

DI: 08800024201368 · Model: Precisil Monophase (50ml * 50 Cartridges) · Sherpakorea
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Precisil Monophase
Primary DI
08800024201368
Version / Model
Precisil Monophase (50ml * 50 Cartridges)
Company Name
Sherpakorea
Labeler DUNS
557822311
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-10-01
Public Version
1
Public Version Date
2019-10-09
Public Version Status
New
Public Device Record Key
4346ce5e-d3d0-4fb8-9cb3-e03569ca5fb2

Device Characteristics

Single Use
Yes
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
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
ELW Material, Impression

GMDN Terms

Code Name
35866 Silicone dental impression material

Identifiers

Type ID
Primary 08800024201368

Customer Contacts