FDA.report

SPROTTE®

Primary DI
04048223014295
Brand
SPROTTE®
Company
Pajunk GmbH Medizintechnologie
Model
041152-30C
Catalog number
041152-30C
Device description
041152-30C
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

Related Records

Contact Domains

Product Codes

CodeName
BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Product Code Classifications

CodeDeviceSpecialtyClass
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14048223014292PreviousGS10
04048223053331PrimaryGS10
04048223014295Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1404822301429214048223014292
04048223053331040482230533314048223053331
04048223014295040482230142954048223014295

GMDN Terms

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.

Device Sizes

TypeValueUnit
Length150Millimeter
Outer Diameter0.7Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

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 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

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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