FDA UDI In Commercial Distribution 🇺🇸 United States

Crystal HD® Mirrror Heads

DI: 10840161306231 · Model: 50R379 · ZIRC DENTAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12

Basic Information

Brand Name
Crystal HD® Mirrror Heads
Primary DI
10840161306231
Version / Model
50R379
Company Name
ZIRC DENTAL PRODUCTS, INC.
Labeler DUNS
064783913
Distribution Status
In Commercial Distribution
Device Count in Pkg
12
Record Status
Published
Publish Date
2022-10-12
Public Version
1
Public Version Date
2022-10-20
Public Version Status
New
Public Device Record Key
bc77d084-6362-480c-ad84-b74a5df5fe7f

Device Description

Stainless Steel Head #3 12pk, 40% brighter than rhodium mirrors, Lens is flush with mirror frame, eliminating the possibility of corrosion build-up, Cone Socket

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
Yes
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EAX Mirror, Mouth

GMDN Terms

Code Name
31776 Dental mirror, reusable

Identifiers

Type ID
Primary 10840161306231
Unit of Use 00840161306234

Device Sizes

Type Value Unit Text
Outer Diameter 20 Millimeter