FDA.report

Disposable Mirrors

Primary DI
00615375002452
Brand
Disposable Mirrors
Company
Kerr Corporation
Model
32285DX
Device description
Black Disposable Mirrors; Size #5 (15/16 Diameter)
Published
2017-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EAXMIRROR, MOUTH

Product Code Classifications

CodeDeviceSpecialtyClass
EAXMirror, MouthDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00615375002452PrimaryGS10
00615375008157Unit of UseGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorUPC-AEAN-13Conversion note
00615375002452140061537500245206153750024520615375002452Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.
00615375008157140061537500815706153750081570615375008157Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.

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
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+18005377123customercare@kavokerrgroup.com

Regulatory Flags

DUNS number
199354556
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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