FDA.report

Crystal HD® Mirrror Heads

Primary DI
10840161306231
Brand
Crystal HD® Mirrror Heads
Company
ZIRC DENTAL PRODUCTS, INC.
Model
50R379
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
Published
2022-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EAXMirror, Mouth

Product Code Classifications

CodeDeviceSpecialtyClass
EAXMirror, MouthDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10840161306231PrimaryGS10
00840161306234Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084016130623110840161306231
00840161306234008401613062348401613062340840161306234

GMDN Terms

TermDefinition
Dental mirror, reusableA hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device.

Device Sizes

TypeValueUnit
Outer Diameter20Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
064783913
Device count
12
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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