FDA.reportPublic FDA data

Dr Scholls Freeze Away 12ct Blue

Primary DI
10888853000135
Brand
Dr Scholls Freeze Away 12ct Blue
Company
SCHOLL'S WELLNESS COMPANY LLC
Model
90000072
Device description
Cryogenic Wart Remover
Published
2021-01-06
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
GEHUnit, Cryosurgical, Accessories

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052259000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052259000DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406Schering-Plough Healthcare Products, Inc.2005-12-14GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888853000135PackageGS112Not in Commercial Distribution
00888853000138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088885300013510888853000135
00888853000138008888530001388888530001380888853000138

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
19738015515alex.terranova@drscholls.com

Regulatory Flags#

DUNS number
117174744
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
true
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
10888853000128Freeze Away Wart Remover900000722025-01-23
10888853004836Freeze Away Pinpoint Skin Tag Remover90000625900006252025-10-01
10888853004867Freeze Away Sub Zero Wart Remover90000619900006192025-09-10
10888853001330Freeze Away Dual Action Wart Remover900003362025-01-23
20888853000101Freeze Away Wart Remover900003352025-01-23
00888853003214Freeze Away Max Plantar Wart Remover900003842024-01-03
10888853003211Freeze Away Max Plantar Wart Remover900003842024-01-03
00888853000053Dr Scholls Freeze Away 7ct Yellow900000902021-01-06
00888853003467Freeze Away Skin Tag Remover900004152022-09-21
00888853000619Dr Scholls Freeze Away Max Wart Remover900000672021-02-03
00888853000084Dr Scholls Freeze Away Dual Action 7ct Blue900001202021-01-06
00888853000114Dr Scholls Freeze Away 7ct Blue900000702021-01-06
00888853000138Dr Scholls Freeze Away 12ct Blue900000722021-01-06
20888853003461Freeze Away Skin Tag Remover900004152022-09-21
10888853002955Freeze Away Dual Action 8ct900003362022-07-12
00888853002958Freeze Away Dual Action 8ct900003362022-07-12
10888853002962Freeze Away 8ct900003352022-07-11
10888853000050Dr Scholls Freeze Away 7ct Yellow900000902021-01-06
10888853000043Dr Scholls Wart Remover 7 CT Yellow900000712020-09-03
00888853000107Dr Scholls Freeze Away Wart Remover7 Ct Blue900000702020-09-03

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