FDA.report

Fisherbrand

Primary DI
00613647024430
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
75002463
Catalog number
13100676
Device description
ACCUSPIN MICROR 17R W STD RTR
Published
2022-09-21
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

Contact Domains

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
00613647024430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00613647024430006136470244306136470244300613647024430

GMDN Terms

TermDefinition
Microsample centrifuge IVDAn electrically-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 in vitro diagnostic procedures; it may also sediment viruses and cellular organelles.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(724)517-2425regulatory.affairs@thermofisher.com

Regulatory Flags

DUNS number
004321519
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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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