FDA.reportPublic FDA data

Pencil Point Spinal Needle

Primary DI
06955741822623
Brand
Pencil Point Spinal Needle
Company
Shanghai SA Medical & Plastic Instruments Co., Ltd.
Model
AN-S II
Device description
"22G x 6"" (150mm),sterile, with Introducer(19G*40mm)"
Published
2020-04-27
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
K120475000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120475000ANESTHESIA CONDUCTION NEEDLESShanghai Samedical & Plastic Instruments Co., Ltd.2012-12-21BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06955741822623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06955741822623069557418226236955741822623

GMDN Terms#

Term, Definition table
TermDefinition
Spinal needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to deliver anaesthetic or analgesic agents intrathecally (in the space under the arachnoid membrane of the brain and spinal cord), withdraw a sample of cerebrospinal fluid (CSF), and/or assist introduction of an intrathecal catheter (e.g., lumboperitoneal shunt, spinal catheter). It is typically fenestrated, spring-tipped, and used for short-term administration; it is typically made of metal and plastic materials. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
654447549
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06955741821466Spinal NeedleAN-S2020-07-27
06955741823316Pencil Point Spinal NeedleAN-S II2020-07-27
06955741822241Pencil Point Spinal NeedleAN-S II2020-04-27
06955741822289Pencil Point Spinal NeedleAN-S II2020-04-27
06955741822340Pencil Point Spinal NeedleAN-S II2020-04-27
06955741822364Pencil Point Spinal NeedleAN-S II2020-04-27
06955741822388Pencil Point Spinal NeedleAN-S II2020-04-27
06955741822401Pencil Point Spinal NeedleAN-S II2020-04-27
06955741822562Pencil Point Spinal NeedleAN-S II2020-04-27
06955741822586Pencil Point Spinal NeedleAN-S II2020-04-27
06955741822609Pencil Point Spinal NeedleAN-S II2020-04-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04048223122730Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122754Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122792Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122815Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122877Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122891Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
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04048223122990Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
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04048223123034Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223124574Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223124581Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223124611Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223124628Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223124635Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
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04048223134092SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
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04048223070499NerveGuard NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076217Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076248Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10