FDA.report

CRYO.S

Primary DI
34039943002373
Brand
CRYO.S
Company
Greiner Bio - One GmbH
Model
977501-BBG
Catalog number
977501-BBG
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

Related Records

Product Codes

CodeName
KDTCONTAINER, SPECIMEN MAILER AND STORAGE, STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
KDTContainer, Specimen Mailer And Storage, SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
24039943002376PackageGS12In Commercial Distribution
34039943002373PackageGS15In Commercial Distribution
14039943002379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2403994300237624039943002376
3403994300237334039943002373
1403994300237914039943002379

GMDN Terms

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

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 DIBrandModelCatalogPublished
24039943000846CELLMASTER6806456806452023-04-01
34039943000850CELLMASTER6806486806482023-04-01
24039943000860CELLMASTER6806586806582023-04-01
34039943000874CELLMASTER6806606806602023-04-01
24039943000884CELLMASTER6806656806652023-04-01
34039943000898CELLMASTER6806686806682023-04-01
24039943000907CELLMASTER6816706816702023-04-01
24039943000914CELLMASTER6816726816722023-04-01
24039943000921CELLMASTER6816756816752023-04-01
24039943000013CRYO.S1212611212612022-12-06
24039943000020CRYO.S1212631212632022-12-06
24039943000037CRYO.S1212771212772022-12-06
24039943000044CRYO.S1212781212782022-12-06
34039943000058CRYO.S1212791212792022-12-06
34039943000065CRYO.S1212801212802022-12-06
24039943000082CRYO.S1222611222612022-12-06
24039943000099CRYO.S1222631222632022-12-06
34039943000102CRYO.S1222721222722022-12-06
24039943000112CRYO.S1222771222772022-12-06
24039943000129CRYO.S1222781222782022-12-06

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