FDA.report

Globe Scientific

Primary DI
00840095608404
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
GCC-S-EU
Device description
Centrifuge, Clinical, 12-Place, 240v, 50Hz, EU Plug (Includes: 12-Place Rotor for use with: 5mL, 7mL and 10mL Tubes and 8 x 15mL Tubes, Sleeves and Risers)
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
00840095608404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095608404008400956084048400956084040840095608404

GMDN Terms

TermDefinition
General-purpose tabletop centrifugeA tabletop- or bench-mounted mains electricity (AC-powered) device used mainly in the clinical laboratory to separate the components of suspensions through low- or medium-speed centrifugal force (typically up to 6,000 or 12,000 rpm). It is typically a compact stationary structure with an electric motor, a vertical shaft, and a horizontal rotor attached to the upper end. This device is mostly used to centrifuge various patient samples (i.e., body fluids), either alone or after addition of reagents or other additives before measuring analytes.

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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