FDA.reportPublic FDA data

MAMAWIRE FIX

Primary DI
G635911810D1
Brand
MAMAWIRE FIX
Company
HISTO S.A.
Model
18 Ga x 10 cm
Catalog number
911810D
Device description
MAMAWIRE Fix Landmark Clip for Interventioned Breast Lesions
Published
2024-05-17
Public version status
Update
Distribution status
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
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
G635911810D2PackageHIBCC5In Commercial Distribution
G635911810D1PrimaryHIBCC0

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 radiological 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. It is not an electromagnetic or optical spatial marker.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G635212005MAMAWIRE20 Ga x 5 cm2120052024-05-17
G635212007MAMAWIRE20 Ga x 7 cm2120072024-05-17
G635212010MAMAWIRE20 Ga x 10 cm2120102024-05-17
G635212012MAMAWIRE20 Ga x 12 cm2120122024-05-17
G635212013MAMAWIRE20 Ga x 13 cm2120132024-05-17
G635212015MAMAWIRE20 Ga x 15 cm2120152024-05-17
G635312005MAMAWIRE PLUS20 Ga x 5 cm3120052024-05-17
G635312007MAMAWIRE PLUS20 Ga x 7 cm3120072024-05-17
G635312010MAMAWIRE PLUS20 Ga x 10 cm3120102024-05-17
G635312012MAMAWIRE PLUS20 Ga x 12 cm3120122024-05-17
G635312013MAMAWIRE PLUS20 Ga x 13 cm3120132024-05-17
G635312015MAMAWIRE PLUS20 Ga x 15 cm3120152024-05-17
G635911810MAMAWIRE FIX18 Ga x 10 cm9118102024-05-17
G635911810B1MAMAWIRE FIX18 Ga x 10 cm911810B2024-05-17
G635911810DB1MAMAWIRE FIX18 Ga x 10 cm911810DB2024-05-17
G635911810DY1MAMAWIRE FIX18 Ga x 10 cm911810DY2024-05-17
G635911810Y1MAMAWIRE FIX18 Ga x 10 cm911810Y2024-05-17
G635360015DANA 2.2 MG G22 mm3600152024-05-17
G635360015G1DANA 2.2 MG G0- 22 mm360015G2024-05-17
G635812020BLO-K 20 Ga x 20 cm8120202024-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450681190Preston™Merit Medical Systems, Inc.DWO2026-08-21
G635212005MAMAWIREHISTO S.A.DWO2024-05-17
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
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