FDA.reportPublic FDA data

McKesson

Primary DI
20612479220076
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
140-0295
Device description
Portable CryoTherapy DE Treatment Kit
Published
2017-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
20612479220076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061247922007620612479220076

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, cryogen gas, mechanicalAn assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) to remove malignant or abnormal benign tissues.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

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