FDA.reportPublic FDA data

ClikSeal™

Primary DI
00819398027823
Brand
ClikSeal™
Company
HARDY DIAGNOSTICS
Model
PC4064200
Catalog number
PC4064200
Device description
ClikSeal Specimen Container, Non Sterile, 120ml, bulk 200/case
Published
2023-03-10
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
NNIContainer, Specimen, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819398027823PrimaryGS10
00819398027816Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398027823008193980278238193980278230819398027823
00819398027816008193980278168193980278160819398027816

GMDN Terms#

Term, Definition table
TermDefinition
General laboratory container, single-useA container (e.g., test tube, bottle, cup, assay tray with large wells) intended to be used as a non-dedicated receptacle to hold consumable laboratory substances (e.g., reagents, buffers), specimens, and other materials associated with procedures in the laboratory; it is not intended for in vitro diagnostic procedures. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
800-266-2222technicalservice@hardydiagnostics.com

Regulatory Flags#

DUNS number
039981550
Device count
200
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816576020058NAE31E312016-09-01
00816576024995N/AG123G1232020-05-18
00816576026968N/AG367G3672024-07-08
00816576027965N/AW95W952020-06-08
00819398028653N/AZ206Z2062020-08-06
00816576027958N/AW95W952020-06-08
00816576024858N/AG105G1052020-05-18
00819398024600N/AY100Y1002020-06-08
00819398024808N/AY110Y1102020-06-09
00819398024907N/AY115Y1152020-06-09
00819398024594N/AY100Y1002020-06-08
00819398023610N/AR76BXR76BX2020-06-05
00819398024242HardyFlask™X26X262020-06-08
00819398025102N/AY130Y1302020-06-09
00819398023603N/AR76BXR76BX2020-06-05
00819398024235HardyFlask™X26X262020-06-08
00819398022118N/AL22L222020-06-03
00819398025560N/AY310Y3102020-06-09
00819398028264N/AMV1MV12020-06-04
00816576027194HardyDisk™Z9495Z94952025-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10840165500567LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500581LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500604LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500628LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500642LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500680LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500703LeakbusterStarplex Scientific Corp.NNI2025-10-07
10827989007731Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2025-09-16
10840165500208HistoplexStarplex Scientific Corp.NNI2025-05-30
10840165500086StarCLICK 100Starplex Scientific Corp.NNI2025-05-28
10840165500109LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500123LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500147LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500161LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500185HistoplexStarplex Scientific Corp.NNI2025-05-28
10840165500406LeakbusterStarplex Scientific Corp.NNI2025-05-28
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10840165401185LeakbusterPretium Canada Packaging ULCNNI2025-04-29
10840165401406LeakbusterPretium Canada Packaging ULCNNI2025-04-29
00616784802138LabChoice Specimen Bags, Clear, 8" x 10"(20.3 cm x 25.4 cm) , 1.8 milDynarex CorporationNNI2025-04-07
00840117333420LabChoice Specimen Bags with Pouch, 4" x 6" (10.2 cm x 15.2 cm), 1.8 milDynarex CorporationNNI2025-04-07
19120126131452VACUETTEGreiner Bio-One GmbHNNI2025-04-02
00616784802039LabChoice Specimen Bags, 6" x 9" (15.2 cm x 22.9 cm), 1.8 mil, Non-SterileDynarex CorporationNNI2025-03-28
00840117333413LabChoice Specimen Bags, 12" x 15" (30.5 cm x 38.1 cm), 1.8 milDynarex CorporationNNI2025-03-28
10860009784892Ditek Urine Collection CupMedzah IndustriesNNI2025-03-06
10840165400966Starplex Pretium Canada Packaging ULCNNI2025-03-04