FDA.reportPublic FDA data

SONOPLEX

Primary DI
04048223031339
Brand
SONOPLEX
Company
Pajunk GmbH Medizintechnologie
Model
001187-85
Catalog number
001187-85
Device description
001187-85
Published
2021-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14048223031336PreviousGS10
04048223050781PrimaryGS10
04048223031339Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404822303133614048223031336
04048223050781040482230507814048223050781
04048223031339040482230313394048223031339

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
Length50Millimeter
Outer Diameter0.55Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
317654283
Device count
10
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
04048223126103NerveStim Pure1151-94-901151-94-902026-02-06
04048223128817SPROTTE®511151-29A511151-29A2025-09-16
04048223129111SPROTTE® NRFit051163-29A051163-29A2025-09-16
04048223129517SPROTTE® NRFit041163-29A041163-29A2025-09-16
04048223129647SPROTTE®071151-30C071151-30C2025-09-16
04048223129678SPROTTE® NRFit021163-30C021163-30C2025-09-16
04048223129692SPROTTE® NRFit031163-27A031163-27A2025-09-16
04048223129838SPROTTE® NRFit061163-29A061163-29A2025-09-16
04048223129999Standard Sprotte Needle321151-29A321151-29A2025-09-16
04048223131398Standard Sprotte Needle341151-31B341151-31B2025-09-16
04048223131428SPROTTE®131151-30C131151-30C2025-09-16
04048223131442SPROTTE®131151-30A131151-30A2025-09-16
04048223131466SPROTTE®141151-30C141151-30C2025-09-16
04048223132050SonoPlex® II Facet S001287-72001287-722025-09-16
04048223132135SonoPlex® II Facet S001287-76001287-762025-09-16
04048223132241SonoPlex® II Facet NRFit001265-74001265-742025-09-16
04048223132319SonoPlex® II Facet NRFit001265-77001265-772025-09-16
04048223132395SonoPlex® II Facet001285-76001285-762025-09-16
04048223132463SonoBlock II Facet001280-74001280-742025-09-16
04048223132562SonoPlex® II Facet S NRFit001267-76001267-762025-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10818788022995Epimed International, Inc.EPIMED INTERNATIONAL, INCBSP2026-03-17
10193489242164MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-12-18
10193489631005MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-12-18
40888277832443MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-12-18
40888277832467MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-12-18
40888277832450MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-12-18
10193494001695PROBLOC* II Insulated Regional Block NeedleAvanos Medical, Inc.BSP2025-12-08
10193494001701PROBLOC* II Insulated Regional Block NeedleAvanos Medical, Inc.BSP2025-12-08
10193494001718PROBLOC* II Insulated Regional Block NeedleAvanos Medical, Inc.BSP2025-12-08
10193494001725PROBLOC* II Insulated Regional Block NeedleAvanos Medical, Inc.BSP2025-12-08
10193494001732PROBLOC* II Insulated Regional block NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001749PROBLOC* II Insulated Regional block NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001756PROBLOC* II Insulated Regional block NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001763PROBLOC* II Insulated Regional block NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001770ECHOBRIGHT* ECHOGENIC Single Shot Tuohy Needle with Stimulating CableAvanos Medical, Inc.BSP2025-11-28
10193494001787ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection SetAvanos Medical, Inc.BSP2025-11-28
10193494001794ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection SetAvanos Medical, Inc.BSP2025-11-28
10193494001800ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection SetAvanos Medical, Inc.BSP2025-11-28
10193494001817ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection SetAvanos Medical, Inc.BSP2025-11-28
10193494001824ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection SetAvanos Medical, Inc.BSP2025-11-28
10193494001831ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection SetAvanos Medical, Inc.BSP2025-11-28
10193494001848ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001855ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001862ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001879ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001886ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001893ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001909ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001916PROLONG* Continuous Nerve Block SetAvanos Medical, Inc.BSP2025-11-28
10193494001923PROLONG* Continuous Nerve Block SetAvanos Medical, Inc.BSP2025-11-28