FDA.reportPublic FDA data

Medline

Primary DI
10193489084788
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
OTCM1501
Catalog number
OTCM1501
Device description
CRYOTHERAPY V 236ML KIT 6 CONES+60 BUDS
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10193489084788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019348908478810193489084788

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, Specify00Do not store near direct heat sources or in condition over 120 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
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
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04050147024694ErbeErbe Elektromedizin GmbHGEH2026-05-26
00860009734821Artemis-TPOSEigen Health Services LLCGEH2026-01-28
00194346615124EquateWAL-MART STORES, INC.GEH2025-12-22
06935650602042HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650602059HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650602066HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650602073HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603049HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603056HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603063HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603070HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603087HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603094HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603100HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603117HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603124HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603131HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603148HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603155HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603162HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603179HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603186HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603193HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603216HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603223HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603230HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603247HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603254HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08
06935650603209HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-07
07350006441011CryoIQ 25g N2O cartridgeCryoIQ global ABGEH2025-07-16