FDA.reportPublic FDA data

NEUWAVE

Primary DI
00818913020677
Brand
NEUWAVE
Company
NEUWAVE MEDICAL, INC.
Model
DR-001446
Catalog number
CTBKT5
Device description
CT Bed Rail Mount, Flat
Published
2021-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BWNTABLE AND ATTACHMENTS, OPERATING-ROOM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWNTable And Attachments, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818913020677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818913020677008189130206778189130206770818913020677

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth88Millimeter
Width645Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
809758878
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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
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
00853719006067Certus® 1402.45 GHz Ablation SystemLK15cm - 15ga2016-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995363321NASTERIS CORPORATIONBWN2026-10-08
00724995363338NASTERIS CORPORATIONBWN2026-10-08
00724995363345NASTERIS CORPORATIONBWN2026-10-08
00724995363352NASTERIS CORPORATIONBWN2026-10-08
00724995363888NASTERIS CORPORATIONBWN2026-10-08
00724995363895NASTERIS CORPORATIONBWN2026-10-08
00842102116506StrongArm Surgical Holders and PositionersFLEXBAR MACHINE CORPORATIONBWN2026-10-07
00815849025615Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.BWN2026-10-06
00851674008683SmartSurface Riser - Stryker D860Elucent Medical, Inc.BWN2026-09-28
00842102116469Flexarm Surgical Holders and PositionersFLEXBAR MACHINE CORPORATIONBWN2026-08-03
00842180148864ELMED INCORPORATEDELMED INCORPORATEDBWN2026-06-08
00724995232030NASTERIS CORPORATIONBWN2026-05-26
10381780542254MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONBWN2026-02-05
10381780542261MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONBWN2026-02-05
03701602300044ARCH - Boot SInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300051ARCH - Boot MInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300068ARCH - Boot MInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300075ARCH - Boot SInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300099Velcro Strap longInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300105PURIST - Leg positioning systemInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300112PURIST / OLH - Boot S - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300129PURIST / OLH - Boot M - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300136OLH #ERDP - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300143OLH #ERD - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300150OLH #ER - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300167OLH #BHA- BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300174OLH #ED - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300181OLH - DENYER PLUS - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300198OLH - DENYER - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300204OLH - US/EU - BInnovative Orthopedic Technologies AGBWN2026-01-13