FDA.report

Globe Scientific

Primary DI
00840095601283
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
112117
Device description
** NEW & IMPROVED ** Cuvette, Semi-Micro, 2.9mL, with 2 Clear Sides, PS, 100/Tray, 10 Trays/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
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications

CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840095601276PackageGS12In Commercial Distribution
00840095643405PackageGS112In Commercial Distribution
00840095601283PrimaryGS10
00840095609111Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095601276008400956012768400956012760840095601276
00840095643405008400956434058400956434050840095643405
00840095601283008400956012838400956012830840095601283
00840095609111008400956091118400956091110840095609111

GMDN Terms

TermDefinition
Laboratory analyser cuvette IVD, single-useA non-sterile, small volume, rectangular column designed to contain a clinical specimen, reagent, or other material for testing procedures performed by a laboratory analyser. It is transparent to allow light to travel through sample and is typically made of plastic, glass or quartz with a flat base and an open top. 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

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