FDA.reportPublic FDA data

SonoPlex® II Facet

Primary DI
04048223130681
Brand
SonoPlex® II Facet
Company
Pajunk GmbH Medizintechnologie
Model
001285-77
Catalog number
001285-77
Device description
SonoPlex® II Facet 21G (0,80) x 100mm, with injection tube and connecting cable
Published
2025-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K243682000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243682000SonoPlex STIM; SonoPlex IIPAJUNK GmbH Medizintechnologie2025-06-27BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048223132067PackageGS110In Commercial Distribution
04048223130681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048223132067040482231320674048223132067
04048223130681040482231306814048223130681

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating anaesthesia needleA sterile device intended to functions as: 1) an electrode during nerve/nerve plexus location; and 2) as a conduit for administration of a local anaesthetic during peripheral nerve-blocking. It is a sharp, hollow, tubular, electrically-insulated metal needle with an uninsulated bevelled tip, intended to be used with an electrical pulse generator and an appropriate anaesthetic-filled syringe. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length100Millimeter
Outer Diameter0.8Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1 770-493-6832info@pajunk-usa.com

Regulatory Flags#

DUNS number
317654283
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048223056165VASCULAR SONO1187-4F0351187-4F0352021-04-02
04048223056172VASCULAR SONO1187-4F0701187-4F0702021-04-02
04048223056189VASCULAR SONO1187-4K0401187-4K0402021-04-02
04048223056196VASCULAR SONO1187-4K0701187-4K0702021-04-02
04048223056202VASCULAR SONO1187-4K1001187-4K1002021-04-02
04048223115947VASCULAR SONO1187-4F0351187-4F0352021-07-07
04048223115954VASCULAR SONO1187-4F0701187-4F0702021-07-07
04048223115961VASCULAR SONO1187-4K0401187-4K0402021-07-07
04048223115978VASCULAR SONO1187-4K0701187-4K0702021-07-07
04048223115985VASCULAR SONO1187-4K1001187-4K1002021-07-07
04048223126561VascularSono1187-4K0701187-4K0702025-06-17
04048223126653VascularSono1187-4K1001187-4K1002025-11-04
04048223126721VascularSono1187-4F0701187-4F0702025-11-04
14048223021153VascularSono1187-4K0701187-4K0702016-08-31
14048223021160VascularSono1187-4K1001187-4K1002016-08-31
14048223021344VascularSono1187-4F0351187-4F0352016-08-31
14048223021504VascularSono1187-4K0401187-4K0402016-08-31
14048223021603VascularSono1187-4F0701187-4F0702016-08-31
04048223122655Tuohy II1170-6I0911170-6I0912026-10-22
04048223122679Tuohy II1170-6K0811170-6K0812026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223122655Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122679Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122693Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122716Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
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
04048223122914Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122938Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122952Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122976Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122990Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223123010Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
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
04048223134030SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
04048223134054SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
04048223134078SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
04048223134092SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
04048223139110CauDal SonoPajunk GmbH MedizintechnologieBSP2026-07-06
04048223070499NerveGuard NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076217Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076248Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10