FDA UDI In Commercial Distribution 🇺🇸 United States

Cross Linked 2

DI: EPOLCL45B30 · Model: CL.45B3 · POLIDENT d.o.o.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Cross Linked 2
Primary DI
EPOLCL45B30
Version / Model
CL.45B3
Catalog Number
CL.45B3
Company Name
POLIDENT d.o.o.
Labeler DUNS
644778409
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-11-18
Public Version
1
Public Version Date
2024-11-26
Public Version Status
New
Public Device Record Key
e2cd3aff-1a04-4472-bce6-9bac461c0de8

Device Description

CL45B3

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
ELM Denture, Plastic, Teeth

GMDN Terms

Code Name
38643 Resin artificial teeth

Identifiers

Type ID
Primary EPOLCL45B30

Customer Contacts

Phone
+38653304840