FDA.reportPublic FDA data

Globe Scientific

Primary DI
00840095623179
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
3001
Device description
CryoCLEAR vials, 1.0mL, STERILE, Internal Threads, Attached Screwcap with Co-Molded Thermoplastic Elastomer (TPE) Sealing Layer, Conical Bottom, Self-Standing, Printed Graduations, Writing Space and Barcode, 50/Bag, 10 Bags/Case
Published
2023-06-28
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
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
00840095623162PackageGS190In Commercial Distribution
00840095623179PackageGS110In Commercial Distribution
00840095645973PackageGS12In Commercial Distribution
00840095645966PrimaryGS10
00840095687034Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095623162008400956231628400956231620840095623162
00840095623179008400956231798400956231790840095623179
00840095645973008400956459738400956459730840095645973
00840095645966008400956459668400956459660840095645966
00840095687034008400956870348400956870340840095687034

GMDN Terms#

Term, Definition table
TermDefinition
Microbial cryotube IVDA vial containing porous glass or synthetic polymer beads and/or a liquid cryoprotectant intended to be used for the cryopreservation, storage, and subsequent retrieval of clinical microbial isolates (e.g., bacteria, fungi) for in vitro diagnostic applications. The container enables preservation and storage of the microbial specimens at sub-zero temperatures for extended periods. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106793995
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
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
00840095681674Globe ScientificGCC-P2026-03-16
00840095689441Globe Scientific 154005R2025-07-07
00840095689458Globe Scientific 154020R2025-07-07
00840095689465Globe Scientific 154035R2025-07-07
00840095689472Globe Scientific 154005RS2025-07-07
00840095689489Globe Scientific 154020RS2025-07-07
00840095689496Globe Scientific 154035RS2025-07-07
00840095689502Globe Scientific 154105RS2025-07-07
00840095689519Globe Scientific 154120RS2025-07-07
00840095689526Globe Scientific 154135RS2025-07-07
00840095689533Globe Scientific 154205RS2025-07-07
00840095689540Globe Scientific 154220RS2025-07-07
00840095689557Globe Scientific 154235RS2025-07-07
00840095689595Globe Scientific 154005F2025-07-07
00840095689601Globe Scientific 154020F2025-07-07
00840095689618Globe Scientific 154035F2025-07-07
00840095689625Globe Scientific 154005FS2025-07-07
00840095689632Globe Scientific 154020FS2025-07-07
00840095689649Globe Scientific 154035FS2025-07-07
00840095689656Globe Scientific 154105FS2025-07-07

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
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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