FDA.report

Vera Bradley

Primary DI
00781096550722
Brand
Vera Bradley
Company
MCGEE GROUP, INC., THE
Model
VB Ashlyn Desert Floral
Catalog number
VBASHLYN0DSF0R250
Device description
Magnifying Spectacle 52-19-143 (2.50)
Published
2019-10-04
Public version status
Update
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

Contact Domains

Product Codes

CodeName
HOISpectacle, magnifying

Product Code Classifications

CodeDeviceSpecialtyClass
HOISpectacle, MagnifyingOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00781096550722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00781096550722007810965507227810965507220781096550722

GMDN Terms

TermDefinition
Magnifying spectaclesA device that consists of a spectacle frame with convex lenses intended to enlarge text/images for a visually impaired patient/person. It is made of plastic material or glass within a plastic or metal frame.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(770)442-0010dbeauchamp@mcgeegroup.com

Regulatory Flags

DUNS number
847029543
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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