FDA.reportPublic FDA data

KOVA

Primary DI
00850015517006
Brand
KOVA
Company
KOVA INTERNATIONAL, INC.
Model
87154
Catalog number
87154
Device description
Super-Pac 1000
Published
2020-03-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KEWSlides, Microscope
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEWSlides, MicroscopePathology1
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850015517006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015517006008500155170068500155170060850015517006

GMDN Terms#

Term, Definition table
TermDefinition
General specimen microscopy slide IVD, single-useA glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
714-902-1700cs@kovaintl.com

Regulatory Flags#

DUNS number
078780990
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850015517198Siemens11561696115616962022-03-03
00850015517204Siemens11561695115616952022-03-03
00850015517211Siemens11561694115616942022-03-03
00855617006873KOVA87162871622020-08-12
00855617006521Cardinal Health89102891022020-08-13
00855617006538Cardinal Health89101891012020-08-13
00855617006903KOVA87155871552020-08-12
00855617006910KOVA87153871532020-08-12
00855617006958KOVA87138871382020-08-12
00855617006965KOVA87137871372020-08-12
00855617006804KOVA87140871402020-08-11
00855617006934KOVA87141871412020-08-11
00850015517075KOVA88100881002020-07-30
00855617006064KOVA87153E87153E2020-07-30
00855617006071KOVA87162E87162E2020-07-30
00855617006088KOVA87155E87155E2020-07-30
00855617006095KOVA87156E87156E2020-07-30
00855617006101KOVA87141E87141E2020-07-30
00855617006163KOVA87137E87137E2020-07-30
00855617006170KOVA87138E87138E2020-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810050855850Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
10810050855867Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
10810050855874Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
10810050855881Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
10810050855898Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
G669CNPTLN1Crow's Nest Biopsy Catchment System, Gen II Twist Lock version, Non-SterileCorramedical Inc.NNK2026-04-07
10810050855836Microscope SlidesTYPENEX MEDICAL LLCKEW2026-03-23
B24280EZEX21000Easy 2 Stool Extraction DeviceAMERICAN LABORATORY PRODUCTS COMPANY, LTD.NNK2025-10-30
10194484321588N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-11
10194484321595N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-11
10194484321533N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
10194484321564N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
10194484321571N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
10194484321267N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321274N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321304N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321311N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321328N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321335N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321342N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20849832023214Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832024174Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832024310Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832024327Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832024358Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832025331Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
10810050855775Microscope SlidesTYPENEX MEDICAL LLCKEW2025-07-14
10810050855768Microscope SlidesTYPENEX MEDICAL LLCKEW2025-07-08
20849832016315Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-01
20849832016360Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-01