FDA.reportPublic FDA data

CoreTainer

Primary DI
00815137022036
Brand
CoreTainer
Company
Beekley Corporation
Model
303S
Device description
Stereotactic Core Biopsy Image and Transport System
Published
2019-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00815137022036PrimaryGS10
10815137022026Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815137022036008151370220368151370220360815137022036
1081513702202610815137022026

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, no additive, non-sterileA non-sterile covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of diagnostic specimen (e.g., urine, faeces, sputum, mucous, tissue) for analysis and/or other investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001157841
Device count
2
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20815137022221CaraClip4312023-11-13
00815137022227CaraClip431S2023-11-13
00815137021077ColdSPOT5002019-07-22
00815137021084ColdSPOT5022019-07-22
00815137021060ColdSPOT5052019-07-22
00815137021978ColdSPOT500S2019-07-22
00815137021985ColdSPOT502S2019-07-22
00815137021992ColdSPOT505S2019-07-22
00815137022043TenderTouch4182020-07-31
00815137022050TenderTouch418S2020-07-31
00815137020056PointGuards1152019-07-22
00815137020254PointGuards3152019-07-22
00815137020261PointGuards3162019-07-22
00815137020278PointGuards3182019-07-22
00815137021398PointGuards115S2019-07-22
00815137021541PointGuards215S2019-07-22
00815137021619PointGuards315S2019-07-22
00815137021626PointGuards316S2019-07-22
00815137021633PointGuards318S2019-07-22
00815137022326InkRight5115112024-10-23

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Primary DI, Brand, Company table
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07333066021812EliA Stool Extraction Kit plusPhadia ABNNI2026-06-25
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00827989008090Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2026-06-09
10809160522387HalyardAVID MEDICAL, INC.NNI2026-06-02
08800075627520OSUNG MNDOSUNG MND Co., Ltd.NNI2025-11-03
10840165500741StarCLICK 100Starplex Scientific Corp.NNI2025-10-10
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10840165500703LeakbusterStarplex Scientific Corp.NNI2025-10-07
10827989007731Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2025-09-16
00840117337374LabChoice Pet Cell Bottle, 500 mLDynarex CorporationNNI2025-06-16
00840117337381LabChoice Pet Cell Bottle, 1000 mLDynarex CorporationNNI2025-06-16
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
10840165500420LeakbusterStarplex Scientific Corp.NNI2025-05-28