FDA.report

CVS Health

Primary DI
10050428285586
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
717272
Catalog number
717272
Device description
Ready to Use Wart Freezer Cryogenic Treatment
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GEHUnit, Cryosurgical, Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
GEHUnit, Cryosurgical, AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10050428285586PackageGS16Not in Commercial Distribution
00050428285589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1005042828558610050428285586
00050428285589000504282855890504282855890050428285589

GMDN Terms

TermDefinition
Wart-removal cryogenic kitA collection of devices designed to apply cold from a liquid/gaseous refrigerant (cryogen) to a common or plantar (sole of foot) wart for its removal. The collection typically includes a pressurized cannister with a cryogenic mixture (e.g., liquid dimethyl ether and propane), disposable applicators, a reusable activator that releases the cryogen into the applicators, and cushions; it may also include a liquid wart remover (e.g., salicylic acid) for post-cryo treatment. It is normally available [non-prescription] over-the-counter (OTC). This is a reusable device.

Device Sizes

TypeValueUnit
Height155Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00between 20 and 25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
9413786658fjuliao@asocorp.com

Regulatory Flags

DUNS number
062312574
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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