FDA.reportPublic FDA data

CRYO.S

Primary DI
24039943000082
Brand
CRYO.S
Company
Greiner Bio - One GmbH
Model
122261
Catalog number
122261
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
24039943000082PackageGS1100In Commercial Distribution
34039943000089PackageGS15In Commercial Distribution
14039943000085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2403994300008224039943000082
3403994300008934039943000089
1403994300008514039943000085

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
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
24039943000099CRYO.S1222631222632022-12-06
34039943000102CRYO.S1222721222722022-12-06
24039943000112CRYO.S1222771222772022-12-06
24039943000129CRYO.S1222781222782022-12-06
24039943000136CRYO.S1222791222792022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B686600050ProteX with FlightLock TechnologyRSI Technology Group, LLCKDT2026-04-01
B686600061ProteX with FlightLock TechnologyRSI Technology Group, LLCKDT2026-04-01
04066916044077Tube with cap, 82x13mmSarstedt Aktiengesellschaft & Co.KGKDT2025-09-26
04038917310949Biosphere® screw cap, whiteSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917326698Biosphere® Screw Cap, greenSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917328289Biosphere® screw cap, orangeSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917369909Biosphere® Screw Cap, redSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411769Biosphere® screw cap, yellowSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411790Biosphere® Screw Cap, violetSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411820Biosphere® Screw Cap, blueSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411851Biosphere® Screw Cap, blackSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411882Biosphere® screw cap, neutralSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
G669CNBOX1CST0Crow's Nest Biopsy Catchment SystemCorramedical Inc.KDT2025-07-09
G669CNBOX4CST1Crow's Nest Biopsy Catchment SystemCorramedical Inc.KDT2025-07-09
20809160466947Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.KDT2025-05-15
0406691600597925 ml tube 90x 25Sarstedt Aktiengesellschaft & Co.KGKDT2025-01-28
04066916018405urine cup 76x 60Sarstedt Aktiengesellschaft & Co.KGKDT2025-01-14
04038917923460Srew cap, pinkSarstedt Aktiengesellschaft & Co.KGKDT2024-11-28
04038917923521Srew cap, orangeSarstedt Aktiengesellschaft & Co.KGKDT2024-11-28
04038917994590SC MTube 0,5 ml Sarstedt Aktiengesellschaft & Co.KGKDT2024-11-28
04038917242578Tube 50ml, 114x28mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-10-16
04038917189705Tube 50ml, 115x28mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-10-07
04038917408578Tube 5ml, 75x13mmSarstedt Aktiengesellschaft & Co.KGKDT2024-09-23
04038917994248Micro tube 0.5ml, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-09-23
04038917996570Micro tube 0.5ml, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-09-23
04066916005399Urine cup NFT 100ml temp. labSarstedt Aktiengesellschaft & Co.KGKDT2024-07-22
04038917410021Tube 39 x 13 Sarstedt Aktiengesellschaft & Co.KGKDT2024-05-22
10850054552041US Paramed Collection Oral Fluid KitQuest DiagnosticsKDT2024-05-01
0403891736996110ml Yellow CapSarstedt Aktiengesellschaft & Co.KGKDT2024-04-26
040389179925418,5 ml Urine Monovette Sarstedt Aktiengesellschaft & Co.KGKDT2024-04-26