FDA.reportPublic FDA data

Dash 6 NRFit™

Primary DI
05060498307369
Brand
Dash 6 NRFit™
Company
INTERVENE GROUP LIMITED
Model
15090002
Catalog number
15090002
Device description
Dash 6, Introducer Needle, NRFit® Accessories, Single Use 18G x 38mm
Published
2023-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060498307352PackageGS14In Commercial Distribution
05060498307369PackageGS120In Commercial Distribution
05060498307345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060498307352050604983073525060498307352
05060498307369050604983073695060498307369
05060498307345050604983073455060498307345

GMDN Terms#

Term, Definition table
TermDefinition
Needle guide, single-useA rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as guides for urethral injections, guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. Disposable imaging-supportive devices (e.g., ultrasound transducer cover) may be included with the device. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
735285129
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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
05060498301565Dash 615231022152310222024-01-22
05060498301688Dash 615311022153110222024-01-22
05060498306881Dash 615310022153100222024-01-22
05060498301022Dash 615011010150110102023-06-02
05060498301053Dash 615011030150110302023-06-02
05060498301084Dash 615011050150110502023-06-02
05060498301114Dash 615011100150111002023-06-02
05060498301145Dash 615011200150112002023-06-02
05060498301176Dash 615011600150116002023-06-02
05060498301206Dash 615021010150210102023-06-02
05060498301237Dash 615021030150210302023-06-02
05060498301268Dash 615021050150210502023-06-02
05060498301329Dash 615021100150211002023-06-02
05060498301381Dash 615021200150212002023-06-02
05060498307017Dash 615020200150202002023-06-02
05060498307031Dash 615020100150201002023-06-02
05060498307055Dash 615020050150200502023-06-02
05060498307062Dash 615020030150200302023-06-02
05060498307079Dash 615020010150200102023-06-02
05060498307086Dash 615010600150106002023-06-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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M661S103418350Plastic BD Style Hub Tuohy Epidural NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S103418500Plastic BD Style Hub Tuohy Epidural NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C21600MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C22200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C23200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S90C22600MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
08886479300252Reach NeedleAerin Medical Inc.BSP2024-06-10
M661S80C21200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-02-12
M661S80C21400MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-02-12
00382904003715BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
00382904003722BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
00382904003739BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
00382904003821BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
10193489250428Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489250510Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489778083Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489902822Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10612479261003McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261034McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261065McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261096McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261126McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261157McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10193489253023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2021-08-27
10193489550115MedlineMEDLINE INDUSTRIES, INC.BSP2021-01-28
10193489270990MedlineMEDLINE INDUSTRIES, INC.BSP2021-01-27
10680651479096HalyardAvanos Medical, Inc.BSP2019-07-15
10680651477566HalyardAvanos Medical, Inc.BSP2019-06-15