FDA.reportPublic FDA data

CVS HEALTH

Primary DI
00050428387443
Brand
CVS HEALTH
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
715533-69755CV1
Device description
MEDICAL LIGHT & SCOPE
Published
2020-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXFSpeculum, Illuminated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXFSpeculum, IlluminatedGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10050428387440PackageGS124In Commercial Distribution
00050428387443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005042838744010050428387440
00050428387443000504283874430504283874430050428387443

GMDN Terms#

Term, Definition table
TermDefinition
Otoscope, directAn electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.

Contacts#

Phone, Email table
PhoneEmail
952-890-1940UDI@APOTHECARYPRODUCTS.COM

Regulatory Flags#

DUNS number
062312574
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00050428344095CVS Health4448302026-10-16
00050428034712CVS Health4820172026-10-10
00050428034743CVS Health7312312026-10-10
00050428142349CVS Health7312302026-10-10
00050428142677CVS Health3765472026-10-10
00050428143117CVS Health5516602026-10-10
00050428143124CVS Health5518142026-10-10
00050428339763CVS Health9356852026-10-10
00050428340523CVS Health4820192026-10-10
00050428340936CVS Health3758122026-10-10
00050428341308CVS Health4885982026-10-10
00050428341728CVS Health2100112026-10-10
00050428342053CVS Health4091722026-10-10
00050428342121CVS Health8759562026-10-10
00050428342602CVS Health4448432026-10-10
00050428343869CVS Health8931252026-10-10
00050428346396CVS Health8759502026-10-10
00050428347133CVS Health3835052026-10-10
00050428143315CVSCVS489905V22026-09-18
00050428340561CVSCVS469682V22026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811117106INKAThe Trustee for KAISER FAMILY TRUSTFXF2025-12-01
10097604712429Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXF2022-10-28
00025715697550EZY DOSE KIDSAPOTHECARY PRODUCTS, LLCFXF2020-09-09
20025715697554EZY DOSE KIDSAPOTHECARY PRODUCTS, LLCFXF2020-09-09
10050428387440CVS HEALTHWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFXF2020-07-29
04987669101049DIGITAL MEDICAL SCOPENIDEK CO.,LTD.FXF2017-01-31
04987669101070DIGITAL MEDICAL SCOPENIDEK CO.,LTD.FXF2017-01-31
04987669101018DIGITAL MEDICAL SCOPENIDEK CO.,LTD.FXF2017-01-27