FDA.reportPublic FDA data

SPROTTE® Sono

Primary DI
14048223028398
Brand
SPROTTE® Sono
Company
Pajunk GmbH Medizintechnologie
Model
501185-29A
Catalog number
501185-29A
Device description
SPROTTE® Sono 25G x 3 1/2" (90mm), sterile
Published
2017-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
14048223028398PrimaryGS10
04048223028391Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404822302839814048223028398
04048223028391040482230283914048223028391

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

Contacts#

Phone, Email table
PhoneEmail
+1(888)972-5865info@pajunk-usa.com

Regulatory Flags#

DUNS number
317654283
Device count
25
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
true
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