FDA.reportPublic FDA data

Nalgene™ Cryogenic Tube, 2 mL externally-threaded

Primary DI
10850016058697
Brand
Nalgene™ Cryogenic Tube, 2 mL externally-threaded
Company
Nalge Nunc International Corporation
Model
5012-0020
Device description
BLK STRL CRYOGNCVL, PP;2.0ML
Published
2022-08-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
FMHCONTAINER, SPECIMEN, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30850016058691PackageGS11000Not in Commercial Distribution
10850016058697PrimaryGS10
80840016058239Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085001605869130850016058691
1085001605869710850016058697
8084001605823980840016058239

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
Radiation Sterilization

Regulatory Flags#

DUNS number
080844844
Device count
1000
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850016058390Nunc™ Cryobank™ Vial, 5 mL internally-threaded, Racked3742202022-07-22
10850016058628Nalgene™ System 100™ Cryogenic Tube, 1.5 mL externally-threaded5000-10202022-07-26
10850016058581Nalgene™ Cryogenic Tube, 1.2 mL externally-threaded5000-00122022-06-11
10850016058611Nalgene™ System 100™ Cryogenic Tube, 1 mL externally-threaded5000-10122022-07-26
10850016058406Nunc™ Cryobank™ Vial, 5 mL internally-threaded, Coded-rack374220-BR2022-07-22
10850016058468Nunc™ Cryobank™ Vial, 5 mL internally-threaded, Non-2D, Coded-rack374222-BR2022-07-20
10850016058680Nalgene™ Cryogenic Tube, 1.2 mL externally-threaded5012-00122022-08-08
10850016058505Nunc™ Cryobank™ Vial, 2 mL internally-threaded, Non-2D3742592022-07-25
10850016058499Nunc™ Cryobank™ Vial, 2 mL internally-threaded3742582022-07-20
10850016058437Nunc™ Cryobank™ Vial, 2 mL internally-threaded, Coded-rack374221-BR2022-07-22
10850016058529Nunc™ Cryobank™ Vial, 5 mL internally-threaded3742612022-07-25
10850016058420Nunc™ Cryobank™ Vial, 2 mL internally-threaded, Racked3742212022-07-22
10850016058482Nunc™ Cryobank™ Vial, 2 mL internally-threaded, Non-2D, Coded-rack374223-BR2022-07-29
10850016058475Nunc™ Cryobank™ Vial, 2 mL internally-threaded, Non-2D, Racked3742232022-07-20
10850016058451Nunc™ Cryobank™ Vial, 5 mL internally-threaded, Non-2D, Racked3742222022-07-20
10850016058666Nalgene™ System 100™ Cryogenic Tube, 1.5 mL externally-threaded, Barcoded5001-10202022-08-08
10850016058598Nalgene™ Cryogenic Tube, 2 mL externally-threaded5000-00202022-06-11
10850016058659Nalgene™ Cryogenic Tube, 5 mL externally-threaded, Barcoded5001-00502022-08-08
10850016058413Nunc™ Cryobank™ Vial, 5 mL internally-threaded, Lock-rack374220LOCK2022-07-22
10850016058444Nunc™ Cryobank™ Vial, 2 mL internally-threaded, Lock-rack374221LOCK2022-07-20

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