FDA.report

MAMAWIRE

Primary DI
G6352120122
Brand
MAMAWIRE
Company
HISTO S.A.
Model
20 Ga x 12 cm
Catalog number
212012
Device description
Breast pre - quirurgical breast localization needles
Published
2024-05-17
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

Product Codes

CodeName
DWONeedle, Biopsy, Cardiovascular

Product Code Classifications

CodeDeviceSpecialtyClass
DWONeedle, Biopsy, CardiovascularGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G6352120122PackageHIBCC10In Commercial Distribution
G635212012PrimaryHIBCC0

GMDN Terms

TermDefinition
Radiological image marker, implantableA device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+5401147125941NICOLAS@HISTO.COM.AR

Regulatory Flags

DUNS number
971156914
Device count
1
DM exempt
false
Premarket exempt
true
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 DIBrandModelCatalogPublished
G6352120052MAMAWIRE 20 Ga x 5 cm2120052024-05-17
G6352120072MAMAWIRE 20 Ga x 7 cm2120072024-05-17
G6352120102MAMAWIRE 20 Ga x 10 cm2120102024-05-17
G6352120132MAMAWIRE 20 Ga x 13 cm2120132024-05-17
G6352120152MAMAWIRE 20 Ga x 15 cm2120152024-05-17
G6353120052MAMAWIRE PLUS 20 Ga x 5 cm3120052024-05-17
G6353120072MAMAWIRE PLUS 20 Ga x 7 cm3120072024-05-17
G6353120102MAMAWIRE PLUS 20 Ga x 10 cm3120102024-05-17
G6353120122MAMAWIRE PLUS 20 Ga x 12 cm3120122024-05-17
G6353120132MAMAWIRE PLUS 20 Ga x 13 cm3120132024-05-17
G6353120152MAMAWIRE PLUS 20 Ga x 15 cm3120152024-05-17
G635360015DANA 2.2 MG G22 mm3600152024-05-17
G635360015G1DANA 2.2 MG G0- 22 mm360015G2024-05-17
G6358120202BLO-K 20 Ga x 20 cm8120202024-05-17
G6358120252BLO-K 20 Ga x 25 cm8120252024-05-17
G6359118102MAMAWIRE FIX 18 Ga x 10 cm9118102024-05-17
G635911810B2MAMAWIRE FIX 18 Ga x 10 cm911810B2024-05-17
G635911810D2MAMAWIRE FIX 18 Ga x 10 cm911810D2024-05-17
G635911810DB2MAMAWIRE FIX 18 Ga x 10 cm911810DB2024-05-17
G635911810DY2MAMAWIRE FIX 18 Ga x 10 cm911810DY2024-05-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10884450681203Preston™Merit Medical Systems, Inc.DWO2026-02-03
04046964993312AESCULAPAESCULAP, INC.DWO2026-01-16
04046964993329AESCULAPAESCULAP, INC.DWO2026-01-16
08057276004814Cell-HarvestORM.D.L. S.R.L.DWO2025-04-29
08057276004821Bone-HarvestORM.D.L. S.R.L.DWO2025-04-29
G6352120052MAMAWIREHISTO S.A.DWO2024-05-17
G6352120072MAMAWIREHISTO S.A.DWO2024-05-17
G6352120102MAMAWIREHISTO S.A.DWO2024-05-17
G6352120132MAMAWIREHISTO S.A.DWO2024-05-17
G6352120152MAMAWIREHISTO S.A.DWO2024-05-17
G6353120052MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G6353120072MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G6353120102MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G6353120122MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G6353120132MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G6353120152MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635360015DANA 2.2 MG GHISTO S.A.DWO2024-05-17
G635360015G1DANA 2.2 MG GHISTO S.A.DWO2024-05-17
G6358120202BLO-KHISTO S.A.DWO2024-05-17
G6358120252BLO-KHISTO S.A.DWO2024-05-17
G6359118102MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810B2MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810D2MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810DB2MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810DY2MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G6355512102BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551210C2BIOCORE II MGHISTO S.A.DWO2024-05-16
G6355512132BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551213C2BIOCORE II MGHISTO S.A.DWO2024-05-16
G6355512152BIOCORE II MGHISTO S.A.DWO2024-05-16