FDA.reportPublic FDA data

NovaKit Exam Pack (NovaKit)

Primary DI
10850681007198
Brand
NovaKit Exam Pack (NovaKit)
Company
Novasignal Corp.
Model
NA-DSP2
Catalog number
NA-DSP2
Device description
The NovaKit contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padding, and registration dots.
Published
2020-08-31
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
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180455000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180455000NeuralBotNeural Analytics, Inc.2018-05-22IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850681007198PackageGS110In Commercial Distribution
00850681007191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085068100719810850681007198
00850681007191008506810071918506810071910850681007191

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound support kitA collection of non-sterile, non-powered, noninvasive devices intended to support a noninvasive vascular ultrasound system during location and assessment of vascular flow using ultrasound/Doppler/transit time technology. It consists of non-electronic supportive devices such as patient pads/positioners, transducer covers, and skin marking stickers. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078766464
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850681007399NovaGuide™ 2 Intelligent Ultrasound System05-00030NSC-NVGSYS22022-08-19
00850681007405NovaGuide™ 2 Traditional Ultrasound SystemNSC-TCDNG2NSC-TCDNG22022-08-19
00850681007443NovaGuide™ Intelligent Ultrasound System05-00019NA-RBTSYS12022-08-19
00850681007221Lucid Transcranial Doppler Ultrasound System (Lucid TCD)NA-LUCM1NA-LUCM12020-08-31
00850681007009Lucid Transcranial Doppler SystemM1NA – LUCM12017-05-10
008506810070162-MHz Transducer, Handheld40-00008NA – PRB12017-05-25
008506810070232-MHz Headset/Monitoring Transducer40-00009NA - PRB22017-05-25
00850681007030Temporal Monitoring Headset40-00010NA – MOUNT12017-05-25
00850681007047Remote Control Accessory10-00002NA-ACC22018-03-20
008506810071532Mhz Monitoring Transducer - 8 footNA-PRB3NA-PRB32018-10-17
00850681007160Temporal Monitoring HeadframeNA-MOUNT2NA-MOUNT22018-10-17
00850681007177Monitoring Headframe Foam Procedural SetNA-DSP3NA-DSP32018-10-17
00850681007283NovaKit™ 2 Exam Pack25-00004NSC-NVK2022-08-19
00850681007351NovaKit™ 2 Exam Pack25-00004NSC-NVK2022-08-19
00850681007184NovaBot Automated HeadsetNA-RBT1NA-RBT12020-08-31
10850681007174Temporal Monitoring Headframe Foam Procedural Set, Packaged 10-PackNA-DSP3PKNA-DSP3PK2020-06-05
00850681007115NeuralBot Procedural Set (Single Use)1.xNA-DSP22018-07-26
00850681007122NeuralBot1.xNA-RBT12018-07-09
00850681007191NovaKit Exam Pack (NovaKit)NA-DSP2NA-DSP22020-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928468PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928628PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928703PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928956PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
08800290029376CA2-13MSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036169PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036237BCC2-13SAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.ITX2026-08-07
00841436122078Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436122900Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436124294Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126410Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27