FDA.report

Globe Scientific

Primary DI
00840095600248
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
109117
Device description
Container, Fecal, 30mL, Attached Screwcap with Spoon, PS, Conical Bottom, Self-Standing, 100/Bag, 5 Bags/Unit
Published
2019-11-27
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
NNIContainer, Specimen, Non-Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840095600248PrimaryGS10
00840095608657Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095600248008400956002488400956002480840095600248
00840095608657008400956086578400956086570840095608657

GMDN Terms

TermDefinition
Faecal specimen container IVD, no additiveA covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of a faecal specimen for culture, analysis, and/or other investigation. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
106793995
Device count
500
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
false
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
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

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