FDA.reportPublic FDA data

IntroDucer

Primary DI
04048223063903
Brand
IntroDucer
Company
Pajunk GmbH Medizintechnologie
Model
181151-30L
Catalog number
181151-30L
Device description
IntroDucer 1,40 x 30mm for the Special Sprotte Needle 19G
Published
2025-07-01
Public version status
New
Distribution status
Not 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241953000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241953000SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH Medizintechnologie2024-11-22BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048223063903PackageGS125Not in Commercial Distribution
04048223084489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048223063903040482230639034048223063903
04048223084489040482230844894048223084489

GMDN Terms#

Term, Definition table
TermDefinition
Needle guide, single-useA rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 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
1
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
true
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
04048223122655Tuohy II1170-6I0911170-6I0912026-10-22
04048223122679Tuohy II1170-6K0811170-6K0812026-10-22
04048223122693Tuohy II1170-6K0911170-6K0912026-10-22
04048223122716Tuohy II1170-6K1201170-6K1202026-10-22
04048223122730Tuohy II1170-6M0811170-6M0812026-10-22
04048223122754Tuohy II1170-6M0911170-6M0912026-10-22
04048223122792Tuohy II1170-6O0811170-6O0812026-10-22
04048223122815Tuohy II1170-6O0911170-6O0912026-10-22
04048223122877Tuohy II NRFit1176-6I0911176-6I0912026-10-22
04048223122891Tuohy II NRFit1176-6K0811176-6K0812026-10-22
04048223122914Tuohy II NRFit1176-6K0911176-6K0912026-10-22
04048223122938Tuohy II NRFit1176-6K1201176-6K1202026-10-22
04048223122952Tuohy II NRFit1176-6M0811176-6M0812026-10-22
04048223122976Tuohy II NRFit1176-6M0911176-6M0912026-10-22
04048223122990Tuohy II NRFit1176-6M1201176-6M1202026-10-22
04048223123010Tuohy II NRFit1176-6O0811176-6O0812026-10-22
04048223123034Tuohy II NRFit1176-6O0911176-6O0912026-10-22
04048223124574Tuohy II NRFit1176-6K1031176-6K1032026-10-22
04048223124581Tuohy II NRFit1176-6M1031176-6M1032026-10-22
04048223124611Tuohy II1170-6M1201170-6M1202026-10-22

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