FDA.reportPublic FDA data

VACU-CUT®

Primary DI
00801741083891
Brand
VACU-CUT®
Company
Angiomed GmbH & Co. Medizintechnik KG
Model
17640050
Catalog number
17640050
Device description
VACU-CUT® Disposable Aspiration Biopsy Needle 18g x 100mm
Published
2016-09-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741083898PackageGS110Not in Commercial Distribution
00801741083891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174108389810801741083898
00801741083891008017410838918017410838910801741083891

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length100Millimeter
Needle Gauge18Gauge

Contacts#

Phone, Email table
PhoneEmail
+4972194450ute.dreschner@crbard.com

Regulatory Flags#

DUNS number
320047483
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00801741235979LivertyTIPS610050UTIPS610050U2026-10-07
00801741235986LivertyTIPS610060UTIPS610060U2026-10-07
00801741235993LivertyTIPS610070UTIPS610070U2026-10-07
00801741236006LivertyTIPS610080UTIPS610080U2026-10-07
00801741236013LivertyTIPS610090UTIPS610090U2026-10-07
00801741236020LivertyTIPS610100UTIPS610100U2026-10-07
00801741236105LivertyTIPS610040UTIPS610040U2026-10-07
00801741103131Venovo®VENUM10040VENUM100402019-03-18
00801741103148Venovo®VENUM10060VENUM100602019-03-18
00801741103155Venovo®VENUM10080VENUM100802019-03-18
00801741103162Venovo®VENUM10100VENUM101002019-03-18
00801741103179Venovo®VENUM10120VENUM101202019-03-18
00801741103186Venovo®VENUM10140VENUM101402019-03-18
00801741103193Venovo®VENUM10160VENUM101602019-03-18
00801741103209Venovo®VENUL10040VENUL100402019-03-18
00801741103216Venovo®VENUL10060VENUL100602019-03-18
00801741103223Venovo®VENUL10080VENUL100802019-03-18
00801741103230Venovo®VENUL10100VENUL101002019-03-18
00801741103247Venovo®VENUL10120VENUL101202019-03-18
00801741103254Venovo®VENUL10140VENUL101402019-03-18

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Primary DI, Brand, Company table
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00817295020329InradInradGAA2026-10-09
00817295020336InradInradGAA2026-10-09
00817295020343InradInradGAA2026-10-09
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