FDA.reportPublic FDA data

Kiva

Primary DI
00813478020162
Brand
Kiva
Company
BENVENUE MEDICAL, INC.
Model
ACC5270
Catalog number
ACC5270
Device description
Kiva Introducer Set
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
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813478020162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813478020162008134780201628134780201620813478020162

GMDN Terms#

Term, Definition table
TermDefinition
Bone access cannulaA sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. 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
00813478020087KivaACC1510ACC15102016-09-24
00813478020094KivaACC1520ACC15202016-09-24
00813478020100KivaACC5220ACC52202016-09-24
00813478020117KivaACC5225ACC52252016-09-24
00813478020124KivaACC5230ACC52302016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130456789Medco ManufacturingMedco Manufacturing LLCGEA2026-08-25
00810130456796Medco ManufacturingMedco Manufacturing LLCGEA2026-08-25
00810130456819Medco ManufacturingMedco Manufacturing LLCGEA2026-08-25
00190776419066MillenniumAvalign Technologies, Inc.GEA2026-08-23
00190776419639MillenniumAvalign Technologies, Inc.GEA2026-08-23
00850012846741JNW URTRACLSI Solutions, Inc.GEA2026-08-21
00884450681329Preston™Merit Medical Systems, Inc.GEA2026-08-21
00884450681336Preston™Merit Medical Systems, Inc.GEA2026-08-21
00884450681343Preston™Merit Medical Systems, Inc.GEA2026-08-21
00884450681350Preston™Merit Medical Systems, Inc.GEA2026-08-21
04054462902583evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902590evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902606evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902613evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902620evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902637evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902644evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902651evonosevonos GmbH & Co. KGGEA2026-08-21
04054462902668evonosevonos GmbH & Co. KGGEA2026-08-21
00190776417062MillenniumAvalign Technologies, Inc.GEA2026-08-18
00190776407506MillenniumAvalign Technologies, Inc.GEA2026-07-31
00840329838409BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838416BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838430BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838454BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838515BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00810130456710Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
00810130456727Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
00810130456734Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
00810130456741Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23