FDA.reportPublic FDA data

CryoTube 4,5 ml SI Internal thread star foot Round

Primary DI
25713311000261
Brand
CryoTube 4,5 ml SI Internal thread star foot Round
Company
Nunc A/S
Model
379146
Device description
CryoTube 4,5 ml SI Internal thread star foot Round is used for storage and transportation of biological material for in vitro diagnostic.
Published
2022-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
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
25713311000261PackageGS16In Commercial Distribution
35713311000251PackageGS14In Commercial Distribution
15713311000264PrimaryGS10
85713311000232Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2571331100026125713311000261
3571331100025135713311000251
1571331100026415713311000264
8571331100023285713311000232

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
305971764
Device count
50
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15713311000073110X16 U CENT.TUBE SCREWCAP PS/PE SI3482242018-08-17
15713311000097UNIVERSALCONT.25ML CAP,SPOON LABEL SI3605852018-08-17
15713311000110UNIVERSALCONT.25ML W/SCREW &LABEL SI3642462018-08-17
15713311000219CryoTube 1,8 ml SI Internal thread Starfoot Round3686322023-06-19
25713311000223CryoTube 1,8 ml SI Internal thread Starfoot Round3686322023-06-19
15713311000103UNIVERSALCONT.25ML W/SCREW CAP SI3642382018-08-17
15713311000202CryoTube 1,8 ml SI Internal thread Starfoot Round3772672023-02-17
25713311000209CryoTube 1,8 ml SI Internal thread Starfoot Round3772672023-02-17
15713311000127NUNC IVF MULTIDISH 4 WELL NUNCLON1444442018-09-21
15713311000134NUNC IVF DISH 35mmNON-TREATED1502552018-09-21
15713311000141NUNC IVF DISH 60mmNON-TREATED1502702018-09-21
15713311000158NUNC IVF DISH 90mmNON-TREATED1503602018-09-21
15713311000165NUNC IVF MULTIDISH4 WELL NON-TREATED1798302018-09-21
05713311000014NUNC IVF MULTIDISH 4 WELL NUNCLON1444441444442016-09-01
0571331100002160X15 IVF PETRID NONTREATED VENTS1502701502702016-09-01
05713311000038IVF 4 WELL DISH NONTREATED1798301798302016-09-01
0571331100004535X10 IVF PETRIDISH NONTREATED VENTS1502551502552016-09-01
0571331100005290X17 IVF PETRIDISH NONTREATED VENTS1503601503602016-09-01
15713311000233CryoTube 1,8 ml SI Internal thread Round3634012022-11-18
15713311000240CryoTube 1,0 ml SI, Internal thread, Conical3666562022-11-18

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Primary DI, Brand, Company table
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