FDA.report

BIOCORE II MG

Primary DI
G635551210C2
Brand
BIOCORE II MG
Company
HISTO S.A.
Model
12 Ga x 10 cm
Catalog number
551210C
Device description
Biopsy Needle Biocore II MG
Published
2024-05-16
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
G635551210C2PackageHIBCC10In Commercial Distribution
G635551210C1PrimaryHIBCC0

GMDN Terms

TermDefinition
Side-notch biopsy gun needleAn invasive tubular surgical instrument designed to be connected to a biopsy gun handpiece (not included) for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It is a percutaneously-inserted needle with a side-notch cutter at the distal end which when activated causes a sharp, sliding cannula to slice a segment of tissue. 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 single-use 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
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

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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
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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

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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
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G6355512132BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551213C2BIOCORE II MGHISTO S.A.DWO2024-05-16
G6355512152BIOCORE II MGHISTO S.A.DWO2024-05-16