FDA.report

Globe Scientific

Primary DI
00840095600910
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
110711
Device description
Sample Cup, 0.25mL, PS, 1000/Bag
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
00840095600927PackageGS110In Commercial Distribution
00840095600910PrimaryGS10
00840095608954Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095600927008400956009278400956009270840095600927
00840095600910008400956009108400956009100840095600910
00840095608954008400956089548400956089540840095608954

GMDN Terms

TermDefinition
Assay container IVD, single-useA non-sterile reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
106793995
Device count
1000
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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