FDA.reportPublic FDA data

Nerve Block Needle

Primary DI
04526737170572
Brand
Nerve Block Needle
Company
HAKKO CO.,LTD.
Model
SB80-22
Device description
"22G x 3 1/8""(80mm)30 degree bevelWith 1cm calibrations, depth guide"
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
K961151000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961151000SPINAL NEEDLESHakko Shoji Co., Ltd.1997-03-19BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14526737170579PackageGS110In Commercial Distribution
04526737170572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1452673717057914526737170579
04526737170572045267371705724526737170572

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
Length80Millimeter
Needle Gauge22Gauge

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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04048223122792Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
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04048223124581Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
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04048223139110CauDal SonoPajunk GmbH MedizintechnologieBSP2026-07-06
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