FDA.reportPublic FDA data

Compound W®

Primary DI
10075137000145
Brand
Compound W®
Company
MEDTECH PRODUCTS INC.
Model
NitroFreeze Yellow CWUS009101
Catalog number
N/A
Device description
Compound W® Nitrofreeze™ Nitrous Oxide Wart Removal System - yellow carton secondary sku
Published
2020-01-16
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10075137000145PackageGS16In Commercial Distribution
00075137000148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007513700014510075137000145
00075137000148000751370001480751370001480075137000148

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
Special Storage Condition, Specify00Protect from sunlight Do not expose to temps above 50C(100F) before first use or 35C(95F) after 1st use. Exposure to temps >35C(95F) will activate safety feature disabling the device. Store @room temp

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-443-4908xx@xx.xxx

Regulatory Flags#

DUNS number
060272465
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
08711744032548The Doctor's10304502020-12-08
00042037799229The Doctor's 79922B2020-07-14
00042037799328The Doctor's79932E2020-12-08
00075137000148Compound W®NitroFreeze Yellow CWUS009101N/A2020-01-16
00075137000155Wartner®WPUS0011012020-01-13
00075137440340Compound W®CW017201, CW0121052016-09-16
00075137530058Compound W®CW017201, CW0171052016-09-16
00678112653218Clear Eyes®CE063404, CE063104 2016-09-16
00814832010300EFFERGRIP ADHESIVE 1.5OZ TUBE 24108148320103072022-10-07
00814832010317EFFERGRIP ADHESIVE 2.5OZ TUBE 12108148320103142022-10-07
00814832015862EFFDNT ORIG 44CT TAB 6108148320158692022-11-16
00814832015879EFFERDENT ORIGINAL 102CT TAB 6108148320158762022-11-17
00814832015886EFFDNT ORIG 126CT TAB 6108148320158832022-09-28
00814832015893EFFDNT PLUS MNT 44CT TAB 6108148320158902022-11-16
00814832015909EFFDNT PLUS MNT 90CT TAB 6108148320159062022-11-16
00814832015916EFFDNT PLUS MNT 126CT TAB 6 108148320170542022-09-28
00814832015923EFFERDENT PM 90CT TAB 6108148320159202022-11-17
00814832015930EFFDNT ORIG 252ct CLUB (2x126CT) TAB 12108148320159372022-09-28
00814832017354EFFDNT PM 126CT TAB 6108148320173512022-09-28
07392222170504The Doctor's70502020-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450457549C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-09-05
00860001513745Verruca-Freeze H+CryoSurgery, Inc.GEH2026-07-31
00860001513752Verruca-Freeze H+CryoSurgery, Inc.GEH2026-07-31
00860001513769Verruca-Freeze H+CryoSurgery, Inc.GEH2026-07-31
00860001513790Verruca-Freeze H+CryoSurgery, Inc.GEH2026-07-31
00884450457382C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-07-20
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