FDA.reportPublic FDA data

EchoBlock

Primary DI
04526737170657
Brand
EchoBlock
Company
HAKKO CO.,LTD.
Model
EB-2150
Device description
"21G x 2""(50mm)Facet tip, 30 degree bevelwith fixed tubing"
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
14526737170654PackageGS125In Commercial Distribution
04526737170657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1452673717065414526737170654
04526737170657045267371706574526737170657

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral nerve-block blunt needleA sterile slender hand-held metal tube with a dull, straight or bent (coude) tip designed to atraumatically access a peripheral nerve for the injection of 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

Contacts#

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

Regulatory Flags#

DUNS number
693273427
Device count
1
Lot or batch
true
Expiration date on label
true

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
14526737171170EchoStim MSKEBA-21502022-10-01
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

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Primary DI, Brand, Company table
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M661S80C21600MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C22200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
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M661S80C21200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-02-12
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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
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