FDA.report

Disposable Mouth Mirrors

Primary DI
00723896010655
Brand
Disposable Mouth Mirrors
Company
PRACTICON, INC.
Model
A002-1 STERILE
Catalog number
7087210
Device description
Our Disposable Mouth Mirrors make nice giveaways for patient home care while helping reduce sterilization time and expense. Front surface acrylic mirror with white plastic octagonal handle.
Published
2018-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
EAXMirror, Mouth

Product Code Classifications

CodeDeviceSpecialtyClass
EAXMirror, MouthDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00723896010655PackageGS136In Commercial Distribution
00723896011928PackageGS124In Commercial Distribution
00723896010648PrimaryGS10
00723896007600Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00723896010655007238960106557238960106550723896010655
00723896011928007238960119287238960119280723896011928
00723896010648007238960106487238960106480723896010648
00723896007600007238960076007238960076000723896007600

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
119193803
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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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