FDA.reportPublic FDA data

IntroDucer

Primary DI
14048223000073
Brand
IntroDucer
Company
Pajunk GmbH Medizintechnologie
Model
001151-30L
Catalog number
001151-30L
Device description
1,0 x 30mm
Published
2016-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14048223000073PrimaryGS10
04048223000076Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404822300007314048223000073
04048223000076040482230000764048223000076

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, single-useA rigid, non-powered device designed to lead a 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 many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. 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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048223049860MANOMETER001163-38F001163-38F2021-04-02
04048223050163RFTL001165-20C001165-20C2021-04-02
04048223050248RFTL001165-30D001165-30D2021-04-02
04048223051757SONOPLEX001285-71001285-712021-04-02
04048223051801SONOPLEX001285-77001285-772021-04-02
04048223052303RFTL011165-40D011165-40D2021-04-02
04048223102541UNIPLEX® NANOLINE001156-72001156-722021-04-02
04048223102572UNIPLEX® NANOLINE001156-77001156-772021-04-02
04048223103319SONOBLOCK001180-71001180-712021-04-02
04048223103449SONOPLEX001185-71001185-712021-04-02
04048223103463SONOPLEX001185-74001185-742021-04-02
04048223103562SONOPLEX001187-74001187-742021-04-02
04048223107058SONOTAP1185-3E0501185-3E0502021-04-02
04048223115756TUOHY1150-7G1031150-7G1032021-07-07
04048223116043SONO MSK1191-4C0501191-4C0502021-07-07
04048223116074SONO MSK1191-4E0701191-4E0702021-07-07
04048223116081SONO MSK1191-4E0901191-4E0902021-07-07
04048223116098SONO MSK1191-4E1001191-4E1002021-07-07
04048223116265SONOTAP II1285-3E0501285-3E0502021-07-07
04048223116272SONOTAP II1285-3E0801285-3E0802021-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9176201020Surgical DirectSurgical Direct, Inc.MDM2026-07-13
03661219436348LANDANGERLANDANGERMDM2026-07-12
00810158210615PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00810158215917PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713015PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713039PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713046PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713053PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
03661219436522LANDANGERLANDANGERMDM2026-07-08
03661219436584LANDANGERLANDANGERMDM2026-07-08
03661219436706LANDANGERLANDANGERMDM2026-07-08
04054462915583evonosevonos GmbH & Co. KGMDM2026-06-25
00198506091612ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-24
00198506091629ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-24
00810158211179PRINCETONPrinceton Medical Group, Inc.MDM2026-06-23
00198506091353ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
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B356KE392100American MedicalsAmerican MedicalsMDM2026-05-29
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08717903490617Humeca MAX Carrier 1:1 Humeca B.V.MDM2026-03-31