FDA.reportPublic FDA data

Dash 6 NRFit™

Primary DI
05060498307345
Brand
Dash 6 NRFit™
Company
GBUK 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
Update
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 different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.

Regulatory Flags#

DUNS number
220705343
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
10850002550006EnteralVED-691VED-6912022-11-01
10850002550013EnteralVED-692VED-6922022-11-01
10850002550020EnteralVED-693VED-6932022-11-01
10850002550037EnteralVED-694VED-6942022-11-01
10850801006995EnteralVED-690VED-6902022-11-01
00850801006967EnteralVED-670VED-6702022-10-20
05056038302895TenderTipTT02-05-E31TT02-05-E312023-06-02
05056038302925TenderTipTT02-06-E31TT02-06-E312023-06-02
05056038302956TenderTipTT02-06-P31TT02-06-P312023-06-02
05056038302987TenderTipTT02-07-P31TT02-07-P312023-06-02
05056038303014TenderTipTT02-08-E31TT02-08-E312023-06-02
05056038303045TenderTipTT02-08-P31TT02-08-P312023-06-02
05056038303083TenderTipTT02-10-E54-NTT02-10-E54-N2023-06-02
05056038303137TenderTipTT02-12-E54-NTT02-12-E54-N2023-06-02
05056038303175TenderTipTT02-12-T34-NTT02-12-T34-N2023-06-02
05056038303212TenderTipTT02-14-E54-NTT02-14-E54-N2023-06-02
05056038303250TenderTipTT02-14-T34-NTT02-14-T34-N2023-06-02
05056038303298TenderTipTT03-12-E54-NTT03-12-E54-N2023-06-02
05056038303335TenderTipTT03-12-T34-NTT03-12-T34-N2023-06-02
05056038303373TenderTipTT03-14-E54-NTT03-14-E54-N2023-06-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04048223070499NerveGuard NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076217Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076248Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076347Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
10198459468025MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-08-18
M661S103417350Plastic BD Style Hub Tuohy Epidural NeedleSpectra Medical Devices, LLCBSP2024-06-18
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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
05060498301626Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498301657Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498301770Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498306898Dash 6GBUK GROUP LIMITEDBSP2023-06-02
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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