FDA.report

Globe Scientific

Primary DI
00840095608459
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
GCM-12
Device description
Centrifuge, Micro, 12-Place, High Speed, 120v - 240v, 50/60Hz, US, UK, EU Plugs (Includes: 12-Place Rotor for 1.5mL and 2.0mL Microcentrifuge Tubes)
Published
2019-11-26
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
false

Related Records

Product Codes

CodeName
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Product Code Classifications

CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840095608459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095608459008400956084598400956084590840095608459

GMDN Terms

TermDefinition
Microsample centrifugeA tabletop- or bench-mounted mains electricity (AC-powered) device intended to be used mainly in the clinical laboratory to centrifuge small sample volumes (typically from 0.25 to 2.2 ml) through centrifugal force. It is typically a compact stationary structure with an electric motor, a rotor, a shaft, and speed and time controls. It may include a vortex mixing function and/or refrigerating capabilities to keep cool the rotor chamber or to perform temperature sensitive procedures. The device is intended to spin down microorganisms, cells, precipitates, or reagent solutions prior to subsequent procedures; it may also sediment viruses and cellular organelles.

Sterilization Methods

Method

Regulatory Flags

DUNS number
106793995
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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