FDA.reportPublic FDA data

CVS HEALTH

Primary DI
10050428387440
Brand
CVS HEALTH
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
715533-69755CV1
Device description
MEDICAL LIGHT & SCOPE
Published
2020-07-29
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

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, directA portable, battery-powered, hand-held device (non-endoscopic) primarily designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. The device consists of a handle that contains the batteries (which may be rechargeable), a built-in light to illuminate the interior of the ear canal, and a detachable cone-shaped tube (the speculum) that is inserted in the ear canal. In some cases a moderate air pressure may be applied. Supplemental devices (e.g., additional specula, spare light bulbs) may be included. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
062312574
Device count
1
DM exempt
true
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00050428387443CVS 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