FDA.reportPublic FDA data

Certus® 140

Primary DI
00853719006166
Brand
Certus® 140
Company
NEUWAVE MEDICAL, INC.
Model
2.45 GHz Ablation System
Catalog number
DR-000551
Device description
Certus 140 2.45GHz Ablation System, 120 VAC
Published
2016-09-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NEYSYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEYSystem, Ablation, Microwave And AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853719006166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853719006166008537190061668537190061660853719006166

GMDN Terms#

Term, Definition table
TermDefinition
Microwave ablation system generatorA mains electricity (AC-powered) device intended to generate microwave energy for localized non-vascular soft-tissue ablation, typically to treat tumours and/or hydatid cysts. The generator connects via a delivery cable to a probe (not included) for delivery of microwaves to the target tissues. It is intended to be used in percutaneous, laparoscopic, or open surgery procedures to ablate tissue typically in the liver, lung, pancreas and kidney.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)323-9283info@neuwave.com

Regulatory Flags#

DUNS number
809758878
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10818913020698NEUWAVEPRS35PRS352024-06-14
20818913020695NEUWAVEPRS35PRS352024-06-14
00818913020509NEUWAVEPRS15PRS152020-12-08
00853719006494NEUWAVERC17PKRC17PK2017-04-13
00853719006951NEUWAVENWA1US1NNWA1US1N2017-11-03
00853719006968NEUWAVENWC1US1RNWC1US1R2018-08-26
00818913020677NEUWAVEDR-001446CTBKT52021-10-14
00818913020196NEUWAVENWF1US1NNWF1US1N2017-09-22
00818913020257NEUWAVEAC-UPGRADEAC-UPGRADE2021-05-06
00853719006753NEUWAVENWC1US1NNWC1US1N2017-11-03
00818913020073NEUWAVENWF2HK1NNWF2HK1N2021-03-31
00818913020158NEUWAVENWF2SG1NNWF2SG1N2021-03-31
00818913020172NEUWAVENWF2CN1NNWF2CN1N2021-03-31
00818913020189NEUWAVEDR-000894DR-0008942021-03-31
00853719006005Certus® 1402.45 GHz Ablation SystemPR15cm - 17ga2016-09-18
00853719006012Certus® 1402.45 GHz Ablation SystemPR20cm - 17ga2016-09-18
00853719006029Certus® 1402.45 GHz Ablation SystemPR15cm - 15ga2016-09-18
00853719006036Certus® 1402.45 GHz Ablation SystemPR20cm - 15ga2016-09-18
00853719006043Certus® 1402.45 GHz Ablation SystemLK15cm - 17ga2016-09-18
00853719006050Certus® 1402.45 GHz Ablation SystemLK20cm - 17ga2016-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935650621319HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650621333HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650621357HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650621371HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622613HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622620HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622637HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622651HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622668HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622682HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622699HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622729HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650623344HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650623351HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650624327HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626048HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626451HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626468HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
05060359560971MicroBlate FineCREO MEDICAL LIMITEDNEY2025-05-05
05060359560490MicroBlate FineCREO MEDICAL LIMITEDNEY2025-05-05
06954414601015Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601022Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601039Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601046Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601053Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601060Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601077Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601084Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601107Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601121Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14