FDA.reportPublic FDA data

DANA 2.2 MG G

Primary DI
G635360015
Brand
DANA 2.2 MG G
Company
HISTO S.A.
Model
22 mm
Catalog number
360015
Device description
Automatic Biopsy Gun for Soft tissue Biopsy Needles
Published
2024-05-17
Public version status
Update
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
G635360015PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Biopsy gun handpieceA hand-operated, non-electronic, surgical instrument designed to be used with a dedicated disposable biopsy gun needle (not included) for the automatic extraction of a soft-tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It has a spring-loaded mechanism with a release trigger intended to accept and operate the cutting mechanism of a percutaneous biopsy needle. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a reusable device.

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
971156914
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G635360015G1DANA 2.2 MG G0- 22 mm360015G2024-05-17
G635212005MAMAWIRE 20 Ga x 5 cm2120052024-05-17
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
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
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