FDA.report

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
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
G635360015PrimaryHIBCC0

GMDN Terms

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

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
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
G6352120122MAMAWIRE 20 Ga x 12 cm2120122024-05-17
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
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
G6352120122MAMAWIREHISTO 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
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