FDA.report

Wolverine

Primary DI
00715317815772
Brand
Wolverine
Company
Kenmark Optical, Inc.
Model
S041CL00
Device description
W041 Side Shield Clear Spectacle
Published
2021-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HOISpectacle, magnifying

Product Code Classifications

CodeDeviceSpecialtyClass
HOISpectacle, MagnifyingOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00715317815772PrimaryGS10

GMDN Terms

TermDefinition
Prescription spectaclesAn ophthalmic device consisting of a spectacle frame with a pair of optical spectacle lenses (typically made of plastic or glass, also known as eyeglasses) designed to be worn in front of the user's eyes to provide refractive corrections to eyesight conditions such as presbyopia (the eye's diminished power of accommodation that occurs with ageing), or refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be tinted (sunglasses) to protect the eyes from bright light and radiation.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(502)267-4486gudid@kenmarkeyewear.com

Regulatory Flags

DUNS number
062952593
Device count
1
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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