FDA.reportPublic FDA data

Kiva

Primary DI
00813478020087
Brand
Kiva
Company
BENVENUE MEDICAL, INC.
Model
ACC1510
Catalog number
ACC1510
Device description
CorePlus Bone Biopsy Needle, 15GA
Published
2016-09-24
Public version status
Update
Distribution status
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
00813478020087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813478020087008134780200878134780200870813478020087

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral bone biopsy procedure kit, single-useA collection of sterile devices, equipment, and supplies used to obtain a bone specimen from the vertebrae of a patient (the bony segments of the spinal column) for histological analysis. It typically contains a metal cannula which can have various tip designs (e.g., bevelled, pyramidal, scoop-, or diamond-shaped) and stylet(s), a biopsy needle, an obturator, a needle holder, syringes, and connecting tube. The specimen can be used for the detection of cancer, infection, or other bone disorders. The device may also be used for vertebral infusion (e.g., injection of bone cement). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 997-7463info@benvenuemedical.com

Regulatory Flags#

DUNS number
787732689
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813478020377Luna 3DLUN4000LUN40002016-09-24
00813478020391Luna 3DLUN4200LUN42002016-09-24
00813478020001KivaKIV2100KIV21002016-09-24
00813478020018KivaKIV2150KIV21502016-09-24
00813478020025KivaKIV2200KIV22002016-09-24
00813478020032KivaKIV2250KIV22502016-09-24
00813478020049KivaFRS2100FRS21002016-09-24
00813478020056KivaFRS2200FRS22002016-09-24
00813478020414KivaMS3643MS36432016-09-24
00813478020421BlazerMS2079MS20792016-09-24
00813478020438KivaMS3101MS31012016-09-24
00813478020063KivaPLT1900PLT19002016-09-24
00813478020070KivaPLT1910PLT19102016-09-24
00813478020186BlazerBCN3120BCN31202016-09-24
00813478020193BlazerBZK3130BZK31302016-09-24
00813478020094KivaACC1520ACC15202016-09-24
00813478020100KivaACC5220ACC52202016-09-24
00813478020117KivaACC5225ACC52252016-09-24
00813478020124KivaACC5230ACC52302016-09-24
00813478020131KivaACC5240ACC52402016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956570955CARDINAL HEALTHCardinal Health 200, LLCGAA2026-09-04
00884450834022MiniStop Plus™Merit Medical Systems, Inc.GAA2026-08-22
00884450681251Kensington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681268Kensington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681275Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681282Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681299Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681374Bedford™Merit Medical Systems, Inc.GAA2026-08-21
10198956515482CARDINAL HEALTHCardinal Health 200, LLCGAA2026-07-27
05060212050038Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-11
05060212050021Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-10
10192253057461TurkelCardinal Health 200, LLCGAA2026-05-13
08800176593120WHITEROSE MICRO CANNULAUC MedicalGAA2026-04-07
10192253025262MonojectCardinal Health 200, LLCGAA2026-01-16
10192253025125MonojectCardinal Health 200, LLCGAA2026-01-12
08800176593069WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593076WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593083WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176592949WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592956WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592963WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592970WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592987WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592994WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592390WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592406WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592413WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592420WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592444WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592451WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08