FDA.reportPublic FDA data

HyVee

Primary DI
10075450127017
Brand
HyVee
Company
HY-VEE, INC.
Model
007545012701
Catalog number
007545012701
Device description
Wart Freezer One Step Wart Removal
Published
2016-09-19
Public version status
Update
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
GEHUnit, Cryosurgical, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEHUnit, Cryosurgical, AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10075450127017PackageGS16Not in Commercial Distribution
00075450127010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007545012701710075450127017
00075450127010000754501270100754501270100075450127010

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Height155Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify0020-25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
941-378-6658fjuliao@asocorp.com

Regulatory Flags#

DUNS number
006925671
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00075450844337Hy-Vee Saline Wound Wash844332026-02-19
10075450844334Hy-Vee Saline Wound Wash844332026-02-19
00075450825565hyvee0754508255652026-01-05
00075450825572hyvee0754508255722026-01-05
00075450825657hyvee 0754508256572026-01-05
00075450825916hyvee0754508259162026-01-05
00075450826012hyvee 0754508260122026-01-05
00075450841398hyvee0754508413982026-01-05
00075450841442hyvee 0754508414422026-01-05
20075450825569hyvee0754508255652026-01-05
20075450825576hyvee0754508255722026-01-05
20075450825651hyvee 0754508256572026-01-05
20075450825910hyvee0754508259162026-01-05
20075450826016hyvee 0754508260122026-01-05
60075450841390hyvee0754508413982026-01-05
20075450841446hyvee 0754508414422026-01-05
00075450227406Hy-Vee Health Premium Wrist BPMUB-543-HVUB-543-HV2017-09-19
00075450290806HyVee Health One Step Pregnancy Test2016-09-21
00075450123777HyVee Health Early Result Pregnancy Test2016-09-21
00075450259339HyVee Health One Step Pregnancy Test2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450457511C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457528C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457566C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457573C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
10840143902666cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902673cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902680cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902697cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902703cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902710cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902727cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902734cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143904343cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143912164AtriCure® cryoICE® BOXATRICURE, INC.GEH2026-05-27
04050147024694ErbeErbe Elektromedizin GmbHGEH2026-05-26
08800073100148TargetCool-eRecensMedical, Inc.GEH2026-05-14
06974083413115CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413122CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413313CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413320CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413337CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413412CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413528CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413221CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-22
06974083410718CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413214CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413511CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413818CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
00860009734814ArtemisEigen Health Services LLCGEH2026-01-28
00860009734821Artemis-TPOSEigen Health Services LLCGEH2026-01-28