FDA.report

CVS Pharmacy Inc.

Primary DI
30050428573182
Brand
CVS Pharmacy Inc.
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
Mix Tampons CVS
Device description
The device will be offered as a traditional unscented menstrual 100% cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an appli
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HEBTampon, Menstrual, Unscented

Product Code Classifications

CodeDeviceSpecialtyClass
HEBTampon, Menstrual, UnscentedObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30050428573182PackageGS112In Commercial Distribution
00050428573181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3005042857318230050428573182
00050428573181000504285731810504285731810050428573181

GMDN Terms

TermDefinition
Menstrual tampon, unscentedA non-sterile, non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual or other vaginal discharge. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
062312574
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

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