Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004857851

FEI Number

3004857851

Entity Name

HISTO S.A.

City/State/Country

VILLA RAFFO Buenos Aires, AR

Establishment Address

AV. GRAL. PAZ 315, VILLA RAFFO Buenos Aires 1674, AR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HISTO S.A. (Owner Number: 9067502)

Owner / Operator Contact Address

LATERAL ADVS. GRAL. PAZ # 315, 1674 VILLA RAFFO, BUENOS AIRES, AR-NOTA --, AR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881216 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771215 Biocore II MG Soft Tissue Biopsy Needles Code 551210 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771810 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771820 Biocore II MG Soft Tissue Biopsy Needles Code 551825 Biocore II MG Soft Tissue Biopsy Needles Code 551620 Biocore II Soft Tissue Biopsy Needles Code 441415 Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881810 Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881616 Mamawire Plus Breast Localization Needles Code 312005 Mamawire Breast Localization Needles Code 212005 Biocore II MG C Soft Tissue Biopsy Needles Code 551216C Biocore II MG Soft Tissue Biopsy Needles Code 551420 Biocore II MG Soft Tissue Biopsy Needles Code 551416 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771413 Biocore II BR Soft Tissue Biopsy Needles Code 661810 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771416 Mamawire Plus Breast Localization Needles Code 312007 Biocore II MG Soft Tissue Biopsy Needles Code 551410 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771615 Biocore II BR Soft Tissue Biopsy Needles Code 661620 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771813 Biocore II Soft Tissue Biopsy Needles Code 441815 Biocore II BR Soft Tissue Biopsy Needles Code 661610 Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881213 Biocore II BR Soft Tissue Biopsy Needles Code 661615 Biocore II MG Soft Tissue Biopsy Needles Code 551415 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771625 Biocore II MG Soft Tissue Biopsy Needles Code 551625 Biocore II BR Soft Tissue Biopsy Needles Code 661812 Biocore II MG C Soft Tissue Biopsy Needles Code 551220C Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881210 Biocore II BR Soft Tissue Biopsy Needles Code 661625 Biocore II MG Soft Tissue Biopsy Needles Code 551413 Biocore II MG Soft Tissue Biopsy Needles Code 551815 Biocore II Soft Tissue Biopsy Needles Code 441825 Biocore II BR Soft Tissue Biopsy Needles Code 661820 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771410 Biocore II MG Soft Tissue Biopsy Needles Code 551215 Biocore II MG C Soft Tissue Biopsy Needles Code 551210C Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771216 Biocore II MG Soft Tissue Biopsy Needles Code 551610 Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881816 Mamawire Plus Breast Localization Needles Code 312010 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771613 Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881615 Dana 2.2 MG Automatic Biopsy gun for soft tissue biopsy needles Code 360015G Biocore II Soft Tissue Biopsy Needles Code 441412 Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881220 Mamawire Plus Breast Localization Needles Code 312015 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771825 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771210 Blo-K Prostate anesthesia needles Code 812025 Biocore II MG C Soft Tissue Biopsy Needles Code 551413C Biocore II MG Soft Tissue Biopsy Needles Code 551615 Mamawire Fix Breast Marker for intervened lesions 911810 Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881620 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771220 Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881410 Biocore II MG Soft Tissue Biopsy Needles Code 551810 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771816 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771830 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771213 Biocore II MG Soft Tissue Biopsy Needles Code 551830 Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881820 Mamawire Breast Localization Needles Code 212015 Biocore II Soft Tissue Biopsy Needles Code 441610 Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881420 Biocore II MG Soft Tissue Biopsy Needles Code 551613 Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881815 Biocore II MG Soft Tissue Biopsy Needles Code 551816 Biocore II MG C Soft Tissue Biopsy Needles Code 551420C Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881830 Biocore II MG Soft Tissue Biopsy Needles Code 551616 Biocore II BR Soft Tissue Biopsy Needles Code 661412 Biocore II BR Soft Tissue Biopsy Needles Code 661825 Biocore II Soft Tissue Biopsy Needles Code 441830 Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881625 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771815 Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881415 Biocore II MG Soft Tissue Biopsy Needles Code 551216 Blo-K Prostate anesthesia needles Code 812020 Biocore II BR Soft Tissue Biopsy Needles Code 661815 Biocore II MG C Soft Tissue Biopsy Needles Code 551410C Mamawire Breast Localization Needles Code 212013 Biocore II BR Soft Tissue Biopsy Needles Code 661420 Mamawire Breast Localization Needles Code 212010 Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881610 Biocore II MG C Soft Tissue Biopsy Needles Code 551415C Biocore II MG Soft Tissue Biopsy Needles Code 551220 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771620 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771420 Biocore II MG Soft Tissue Biopsy Needles Code 551213 Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881613 Mamawire Plus Breast Localization Needles Code 312013 Biocore II BR Soft Tissue Biopsy Needles Code 661415 Biocore II Soft Tissue Biopsy Needles Code 441615 Mamawire Plus Breast Localization Needles Code 312012 Mamawire Fix D Breast Marker for intervened lesions 911810D Mamawire Breast Localization Needles Code 212012 Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881413 Biocore II Soft Tissue Biopsy Needles Code 441410 Mamawire Breast Localization Needles Code 212007 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771610 Biocore II MG C Soft Tissue Biopsy Needles Code 551416C Biocore II BR Soft Tissue Biopsy Needles Code 661410 Biocore II BR Soft Tissue Biopsy Needles Code 661612 Biocore II Soft Tissue Biopsy Needles Code 441625 Biocore II MG C Soft Tissue Biopsy Needles Code 551213C Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881825 Biocore II MG C Soft Tissue Biopsy Needles Code 551215C Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881416 Biocore II Soft Tissue Biopsy Needles Code 441612 Biocore II Soft Tissue Biopsy Needles Code 441820 Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881813 Biocore II MG Soft Tissue Biopsy Needles Code 551813 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771616 Biocore II FULL Automatic Soft Tissue Biopsy Needles Code 881215 Biocore II Soft Tissue Biopsy Needles Code 441620 Biocore II MG Soft Tissue Biopsy Needles Code 551820 Biocore II Soft Tissue Biopsy Needles Code 441810 Dana 2.2 MG Automatic Biopsy gun for soft tissue biopsy needles Code 360015 Biocore II Soft Tissue Biopsy Needles Code 441420 Biocore II TC Semi Automatic Soft Tissue Biopsy Needles Code 771415 Mamawire Fix D Breast Marker for intervened lesions 911810DY Mamawire Fix Breast Marker for intervened lesions 911810Y

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWO	Needle, Biopsy, Cardiovascular	General, Plastic Surgery	Class 1	878.4800	2004-10-26

Official Correspondent

No official correspondent registered.

US Agent Details

Henry Sand Business: Oceanside RC&T LLC Email: henry.sand@gmail.com Phone: (858) 9431504

Related Public Records

Same Entity

HISTO S.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004857851. Last updated year: 2026. Please use registration number 3004857851 when referencing this establishment in official correspondence.