FDA.reportPublic FDA data

CRYO.S

Primary DI
34039943000355
Brand
CRYO.S
Company
Greiner Bio - One GmbH
Model
126279
Catalog number
126279
Published
2022-12-06
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
KDTCONTAINER, SPECIMEN MAILER AND STORAGE, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDTContainer, Specimen Mailer And Storage, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24039943000358PackageGS1100In Commercial Distribution
34039943000355PackageGS15In Commercial Distribution
14039943000351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2403994300035824039943000358
3403994300035534039943000355
1403994300035114039943000351

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
315685714
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
14039943000153CRYO.S1222891222892022-12-06
14039943001693CRYO.S121277-128121277-1282022-12-06
14039943001709CRYO.S121278-128121278-1282022-12-06
14039943001716CRYO.S121279-128121279-1282022-12-06
14039943001723CRYO.S121280-128121280-1282022-12-06
14039943002010CRYO.S126273-2D1126273-2D12022-12-06
14039943002126CRYO.S127263-2DC127263-2DC2022-12-06
14039943002492CRYO.S126263-2DC126263-2DC2022-12-06
14039943000016CRYO.S1212611212612022-12-06
14039943000023CRYO.S1212631212632022-12-06
14039943000030CRYO.S1212771212772022-12-06
14039943000047CRYO.S1212781212782022-12-06
14039943000054CRYO.S1212791212792022-12-06
14039943000061CRYO.S1212801212802022-12-06
14039943000085CRYO.S1222611222612022-12-06
14039943000092CRYO.S1222631222632022-12-06
14039943000108CRYO.S1222721222722022-12-06
14039943000115CRYO.S1222771222772022-12-06
14039943000122CRYO.S1222781222782022-12-06
14039943000139CRYO.S1222791222792022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G669CNPTLS1Crow's Nest Biopsy Catchment System, Gen II Twist Lock version, SterileCorramedical Inc.KDT2026-04-07
10809160466940Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.KDT2025-05-15
10198459217074Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDT2024-12-22
30193489107337MedlineMEDLINE INDUSTRIES, INC.KDT2024-03-05
30193489107344MedlineMEDLINE INDUSTRIES, INC.KDT2024-03-05
18053326004534BC+™ COPAN ITALIA SPAKDT2022-12-07
38053326010966UriFreeCOPAN ITALIA SPAKDT2022-12-07
00613647005958FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KDT2022-12-07
14039943000016CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000023CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000030CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000047CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000054CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000061CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000085CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000092CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000108CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000115CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000122CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000139CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000146CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000153CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000160CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000177CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000184CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000191CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000207CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000214CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000221CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000238CRYO.SGreiner Bio - One GmbHKDT2022-12-06