FDA.reportPublic FDA data

Globe Scientific

Primary DI
00840095646192
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
3010
Device description
CryoCLEAR vials, 1.0mL, STERILE, External 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
2023-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00840095623421PackageGS190In Commercial Distribution
00840095623438PackageGS110In Commercial Distribution
00840095646208PackageGS12In Commercial Distribution
00840095646192PrimaryGS10
00840095687188Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095623421008400956234218400956234210840095623421
00840095623438008400956234388400956234380840095623438
00840095646208008400956462088400956462080840095646208
00840095646192008400956461928400956461920840095646192
00840095687188008400956871888400956871880840095687188

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.

Regulatory Flags#

DUNS number
106793995
Device count
50
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840095681674Globe ScientificGCC-P2026-03-16
00840095688840Globe Scientific 154005R2025-07-07
00840095688857Globe Scientific 154020R2025-07-07
00840095688864Globe Scientific 154035R2025-07-07
00840095688871Globe Scientific 154005RS2025-07-07
00840095688888Globe Scientific 154020RS2025-07-07
00840095688895Globe Scientific 154035RS2025-07-07
00840095688901Globe Scientific 154105RS2025-07-07
00840095688918Globe Scientific 154120RS2025-07-07
00840095688925Globe Scientific 154135RS2025-07-07
00840095688932Globe Scientific 154205RS2025-07-07
00840095688949Globe Scientific 154220RS2025-07-07
00840095688956Globe Scientific 154235RS2025-07-07
00840095688994Globe Scientific 154005F2025-07-07
00840095689007Globe Scientific 154020F2025-07-07
00840095689014Globe Scientific 154035F2025-07-07
00840095689021Globe Scientific 154005FS2025-07-07
00840095689038Globe Scientific 154020FS2025-07-07
00840095689045Globe Scientific 154035FS2025-07-07
00840095689052Globe Scientific 154105FS2025-07-07

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