FDA UDI In Commercial Distribution 🇺🇸 United States

T-Crystal cartridges Opaque Pink

DI: 07290110506209 · Model: 25mm Diam. Small 42mm long · PERFLEX LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
T-Crystal cartridges Opaque Pink
Primary DI
07290110506209
Version / Model
25mm Diam. Small 42mm long
Catalog Number
112520-05
Company Name
PERFLEX LTD
Labeler DUNS
532176000
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-06-16
Public Version
1
Public Version Date
2020-06-24
Public Version Status
New
Public Device Record Key
26cf4c08-4e3f-443d-b16f-a911ad39623a

Device Description

5 identical cartridges sealed in a vacuum bag ; cartridge dimensions : 25mm diameter ; 42mm long ; each cartridge is filled with 10Gr of T-Crystal Opaque Pink Thermoplastic pellets.

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
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
EBI Resin, Denture, Relining, Repairing, Rebasing

GMDN Terms

Code Name
58288 Dental appliance fabrication material, thermoplastic

Identifiers

Type ID
Primary 07290110506209