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

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