FDA.reportPublic FDA data

MAMAWIRE

Primary DI
G635212005
Brand
MAMAWIRE
Company
HISTO S.A.
Model
20 Ga x 5 cm
Catalog number
212005
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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWONeedle, Biopsy, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWONeedle, Biopsy, CardiovascularGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G6352120052PackageHIBCC10In Commercial Distribution
G635212005PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
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

Contacts#

Phone, Email table
PhoneEmail
+5401147125941NICOLAS@HISTO.COM.AR

Regulatory Flags#

DUNS number
971156914
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G635360015DANA 2.2 MG G22 mm3600152024-05-17
G635360015G1DANA 2.2 MG G0- 22 mm360015G2024-05-17
G635212007MAMAWIRE 20 Ga x 7 cm2120072024-05-17
G635212010MAMAWIRE 20 Ga x 10 cm2120102024-05-17
G635212012MAMAWIRE 20 Ga x 12 cm2120122024-05-17
G635212013MAMAWIRE 20 Ga x 13 cm2120132024-05-17
G635212015MAMAWIRE 20 Ga x 15 cm2120152024-05-17
G635312005MAMAWIRE PLUS 20 Ga x 5 cm3120052024-05-17
G635312007MAMAWIRE PLUS 20 Ga x 7 cm3120072024-05-17
G635312010MAMAWIRE PLUS 20 Ga x 10 cm3120102024-05-17
G635312012MAMAWIRE PLUS 20 Ga x 12 cm3120122024-05-17
G635312013MAMAWIRE PLUS 20 Ga x 13 cm3120132024-05-17
G635312015MAMAWIRE PLUS 20 Ga x 15 cm3120152024-05-17
G635812020BLO-K 20 Ga x 20 cm8120202024-05-17
G635812025BLO-K 20 Ga x 25 cm8120252024-05-17
G635911810MAMAWIRE FIX 18 Ga x 10 cm9118102024-05-17
G635911810B1MAMAWIRE FIX 18 Ga x 10 cm911810B2024-05-17
G635911810D1MAMAWIRE FIX 18 Ga x 10 cm911810D2024-05-17
G635911810DB1MAMAWIRE FIX 18 Ga x 10 cm911810DB2024-05-17
G635911810DY1MAMAWIRE FIX 18 Ga x 10 cm911810DY2024-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G635212007MAMAWIREHISTO S.A.DWO2024-05-17
G635212010MAMAWIREHISTO S.A.DWO2024-05-17
G635212012MAMAWIREHISTO S.A.DWO2024-05-17
G635212013MAMAWIREHISTO S.A.DWO2024-05-17
G635212015MAMAWIREHISTO S.A.DWO2024-05-17
G635312005MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635312007MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635312010MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635312012MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635312013MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635312015MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635812020BLO-KHISTO S.A.DWO2024-05-17
G635812025BLO-KHISTO S.A.DWO2024-05-17
G635911810MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810B1MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810D1MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810DB1MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810DY1MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810Y1MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635551210BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551210C1BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551213BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551213C1BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551215BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551215C1BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551216BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551220BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551220C1BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551410BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551410C1BIOCORE II MGHISTO S.A.DWO2024-05-16