FDA.reportPublic FDA data

Gongdong

Primary DI
86947462400439
Brand
Gongdong
Company
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
Model
C1025
Device description
Specimen cup, 16mm
Published
2022-08-04
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
06947462400433PrimaryGS10
86947462400439Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06947462400433069474624004336947462400433
8694746240043986947462400439

GMDN Terms#

Term, Definition table
TermDefinition
General laboratory container, single-useA container (e.g., test tube, bottle, cup) 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529309049
Device count
5000
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
06947462435855Gongdong3GALSCR-03G2026-04-21
06947462435862Gongdong1GALSCR-01G2026-04-21
06947462435879Gongdong1QTSCR-01Q2026-04-21
06947462400419Gongdong21022023-03-28
06947462430201GongdongQ115A2024-04-07
06947462430218GongdongQ117A2024-04-07
06947462430225GongdongQ118A2024-04-07
06947462430232GongdongQ119A2024-04-07
06947462430249GongdongQ120A2024-04-07
06947462430256GongdongQ121A2024-04-07
06947462405322GongdongGD5334T12023-11-09
86947462405328GongdongGD5334T12023-11-09
06947462400198GongdongG10462022-08-04
06947462400259GongdongG103012022-08-04
06947462400426GongdongC10262022-08-04
06947462400433GongdongC10252022-08-04
06947462491660GongdongG10302022-08-04
06947462491684GongdongG10362022-08-04
16947462492817GongdongGD100UB2023-09-13
16947462494279GongdongGD040UBW2023-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817518026107MarketLab, Inc.MARKETLAB INC.NNI2026-07-16
00817518026268MarketLab, Inc.MARKETLAB INC.NNI2026-07-16
00817518026275MarketLab, Inc.MARKETLAB INC.NNI2026-07-16
07333066021812EliA Stool Extraction Kit plusPhadia ABNNI2026-06-25
00827989008106Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2026-06-10
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
10840165500765StarCLICK 100Starplex Scientific Corp.NNI2025-10-10
10840165500802LeakbusterStarplex Scientific Corp.NNI2025-10-10
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
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