FDA.report

Vera Bradley

Primary DI
00781096533732
Brand
Vera Bradley
Company
MCGEE GROUP, INC., THE
Model
VB Norma Blush Pink
Catalog number
VBNORM0BHP056S16
Device description
Spectacle Frame, Size 56-16-135
Published
2019-10-25
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

Contact Domains

Product Codes

CodeName
HQRApparatus, cautery, radiofrequency, ac-powered

Product Code Classifications

CodeDeviceSpecialtyClass
HQRApparatus, Cautery, Radiofrequency, Ac-PoweredOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00781096533732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00781096533732007810965337327810965337320781096533732

GMDN Terms

TermDefinition
Spectacle frameAn ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. The device may have a protective function (e.g., by including side shields).

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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