FDA.reportPublic FDA data

Automatic Biopsy Needle - BAM 18/20

Primary DI
04262410686014
Brand
Automatic Biopsy Needle - BAM 18/20
Company
ITP Innovative Tomography Products GmbH
Model
BAM 18/20
Device description
The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
Published
2024-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233294000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233294000Automatic Biopsy Needle BAM, Semi-Automatic Needle BIMItp Innovative Tomography Products GmbH2024-06-18KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04262410686014PackageGS110In Commercial Distribution
04262410686007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262410686014042624106860144262410686014
04262410686007042624106860074262410686007

GMDN Terms#

Term, Definition table
TermDefinition
End-cut biopsy gun handpiece/needleA hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, open, cylindrical biopsy needle that allows a full-width tissue sample to be obtained over the entire length of the biopsy when activated. 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length200Millimeter
Needle Gauge18Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius23 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4923454621940sales@innotom.com

Regulatory Flags#

DUNS number
341493551
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
04262410680821Semi-automatic Biopsy Needle - BIM16/10iBIM16/10i2025-09-12
04262410680852Semi-automatic Biopsy Needle - BIM18/10iBIM18/10i2025-09-12
04262410687073Semi-automatic Biopsy Needle - BIM16/20iBIM16/20i2025-09-12
04262410687110Semi-automatic Biopsy Needle - BIM16/15iBIM16/15i2025-09-12
04262410680838Semi-automatic Biopsy Needle - BIM16/10iBIM16/10i2025-09-12
04262410680845Semi-automatic Biopsy Needle - BIM18/10iBIM18/10i2025-09-12
04262410687080Semi-automatic Biopsy Needle - BIM16/20iBIM16/20i2025-09-12
04262410687127Semi-automatic Biopsy Needle - BIM16/15iBIM16/15i2025-09-12
04262410687059Semi-automatic Biopsy Needle - BIM18/15iBIM18/15i2025-07-09
04262410687066Semi-automatic Biopsy Needle - BIM18/15iBIM18/15i2025-07-09
04262410687011Semi-automatic Biopsy Needle - BIM18/20iBIM18/20i2025-04-29
04262410687028Semi-automatic Biopsy Needle - BIM18/20iBIM18/20i2025-04-29
04262410686083Automatic Biopsy Needle - BAM 16/17BAM16/172025-04-23
04262410686106Automatic Biopsy Needle - BAM 16/15BAM16/152025-04-23
04262410686090Automatic Biopsy Needle - BAM 16/17BAM16/172025-04-23
04262410686113Automatic Biopsy Needle - BAM 16/15BAM16/152025-04-23
04262410680166Coaxial Interventional NeedleKIM18/102025-04-08
04262410680173Coaxial Interventional NeedleKIM18/102025-04-08
04262410680340Coaxial Interventional NeedleKIM15/09T2025-03-13
04262410680357Coaxial Interventional NeedleKIM15/09T2025-03-13

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Primary DI, Brand, Company table
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