FDA.reportPublic FDA data

Epredia

Primary DI
00673693084550
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Dry Containers, Unassembled, Unlabelled Bulk Pack
Catalog number
59902
Device description
The Dry Container portfolio is designed to provide the end-user with the flexibility of filling their own container with a specified fixative. These non-sterile containers are supplied unlabeled and unassembled. The Dry Containers do not expire, and storage temperature should be evaluated on an individual basis according to the reagent in which the container is filled.
Published
2024-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
00673693084550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693084550006736930845506736930845500673693084550

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, no additive/mediumAn empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
929504710
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00673693181723EprediaPen-Fix™61052024-11-19
00673693063494EprediaMicrotome Knife, 12 CM, C22220042024-10-29
00673693063500EprediaMicrotome Knife, 16 CM, C1520202024-10-29
00673693063753EprediaMicrotome Knife, 30CM, C1520502024-10-29
00673693063760EprediaMicrotome Knife, 12 CM, D1520602024-10-29
00673693063777EprediaMicrotome Knife, 16 CM, D1520702024-10-29
00673693063784EprediaMicrotome Knife, 22 CM, D1520802024-10-29
00673693063791EprediaMicrotome Knife, 25 CM, D1520902024-10-29
00673693063807EprediaMicrotome Knife, 30 CM, D1521002024-10-29
00673693063814EprediaTungsten Carbide Knife, 16 CM1521202024-10-29
00673693064200EprediaAdamas Blades for Disposable Magnetic Blade Carrie1600102024-10-29
00673693064231EprediaAdamas Blades for Disposable Magnetic Blade Carrie1600402024-10-29
00673693226707EprediaTungsten Carbide D-Profile Microtome Knives56010062024-10-29
00673693263177EprediaMicrotome Knife D-Profile 240 mm22220062024-10-29
00673693568074EprediaHistoPlast IM8331K2024-10-29
00673693220514EprediaMicrotome Knife C-Profile 240 mm22220052024-10-28
00673693232913EprediaStainless-Steel Microtome Knives 12.5 cm76192024-10-28
00673693233149EprediaStandard Microtome Knife 125 mm77022024-10-28
00673693233187EprediaStandard Microtome Knife 250 mm77042024-10-28
00673693233200EprediaStainless-Steel Microtome Knives 18.5 cm77192024-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810180842211LabChoice Sputum Containers, 40 mL Dynarex CorporationNNI2025-06-16
00840117337367LabChoice Pet Cell Bottle, 250 mL Dynarex CorporationNNI2025-06-16
00840117337374LabChoice Pet Cell Bottle, 500 mL Dynarex CorporationNNI2025-06-16
00840117337381LabChoice Pet Cell Bottle, 1000 mL Dynarex CorporationNNI2025-06-16
00840165500218HistoplexStarplex Scientific Corp.NNI2025-05-30
00840165500096StarCLICK 100Starplex Scientific Corp.NNI2025-05-28
00840165500119LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500133LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500157LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500171LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500195HistoplexStarplex Scientific Corp.NNI2025-05-28
00840165500416LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500430LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165401195LeakbusterPretium Canada Packaging ULCNNI2025-04-29
00840165401416LeakbusterPretium Canada Packaging ULCNNI2025-04-29
00840117336414LabChoice 24-Hour Urine Collection Container, 3000 mL Dynarex CorporationNNI2025-04-17
10827989003214Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2025-04-15
00810180841689LabChoice Specimen Bags, Clear, 8" x 10", 1.8 MILDynarex CorporationNNI2025-04-07
00810180841672LabChoice Specimen Bags with Pouch, 4" x 6", 1.8 MIL Dynarex CorporationNNI2025-04-07
29120126131459VACUETTEGreiner Bio-One GmbHNNI2025-04-02
00810180841665LabChoice Specimen Bags, 6" x 9", 1.8 MIL, Non-SterileDynarex CorporationNNI2025-03-28
00810180841658LabChoice Specimen Bags, 12" x 15", 1.8 milDynarex CorporationNNI2025-03-28
10827989003221Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2025-03-13
00810180841467LabChoice Specimen Containers, 60 mL, Non-SterileDynarex CorporationNNI2025-03-11
00810180841474LabChoice Specimen Containers, 100 mL, NonSterileDynarex CorporationNNI2025-03-11
00810180841450LabChoice Specimen Containers, 40 mL, Non-SterileDynarex CorporationNNI2025-03-11
00860009784895Ditek Urine Collection CupMedzah IndustriesNNI2025-03-06
00840165400976Starplex Pretium Canada Packaging ULCNNI2025-03-04
00850025860017ESD Specimen TrayMicro-tech UsaNNI2025-02-28
04250306301219SalivaGene CollectorInvitek Molecular GmbHNNI2025-02-12