FDA.reportPublic FDA data

EchoStim MSK

Primary DI
14526737171170
Brand
EchoStim MSK
Company
HAKKO CO.,LTD.
Model
EBA-2150
Device description
21G x 2"(50mm) Facet tip, 18 degree bevel with screw on tubing non-insulated
Published
2022-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063380000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063380000ECHOSTIM FACET TIPHavel'S, Inc.2007-04-25BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14526737171170PackageGS125In Commercial Distribution
04526737170695PreviousGS10
04526737171173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1452673717117014526737171170
04526737170695045267371706954526737170695
04526737171173045267371711734526737171173

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral nerve-block sharp needleA sterile, sharp bevel-edged, hollow tubular metal instrument intended to invasively access a peripheral nerve to inject an anaesthetic/analgesic agent for nerve-block/pain control (e.g., sleeve blocks, deep muscle blocks, hypogastric blocks, paravertebral blocks, joint blocks, selective nerve root, lumbar sympathetic, Coeliac plexus). It may be used to deliver anaesthetic or analgesic agents directly and/or to allow introduction of a dedicated catheter for administration. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length50Millimeter
Needle Gauge21Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
513-271-2117SAst@havels.com

Regulatory Flags#

DUNS number
693273427
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
04526737171135EchoStim EBEB-21502022-10-01
04526737171159EchoStim EBEB-211002022-10-01
04526737171173EchoStim MSKEBA-21502022-10-01
04526737171197EchoStim MSKEBA-211002022-10-01
04526737171203EchoStim MSKEBA-211502022-10-01
04526737171210EchoStim MSKEBA-22502022-10-01
04526737171227EchoStim MSKEBA-22802022-10-01
04526737171234EchoStim MSKEBA-221002022-10-01
14526737171132EchoStim EBEB-21502022-10-01
04526737171142EchoStim EBEB-21802022-10-01
14526737171156EchoStim EBEB-211002022-10-01
04526737171166EchoStim EBEB-211502022-10-01
04526737171180EchoStim MSKEBA-21802022-10-01
14526737171194EchoStim MSKEBA-211002022-10-01
14526737171200EchoStim MSKEBA-211502022-10-01
14526737171217EchoStim MSKEBA-22502022-10-01
14526737171224EchoStim MSKEBA-22802022-10-01
14526737171231EchoStim MSKEBA-221002022-10-01
04526737120010BIOSUC-C7BIO201002016-09-23
04526737120041Sonopsy-C1SON21502016-09-23

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Primary DI, Brand, Company table
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04048223076248Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076347Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
10198459468025MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-08-18
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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
05060498306928Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498307345Dash 6 NRFit™GBUK GROUP LIMITEDBSP2023-06-02
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