FDA.reportPublic FDA data

Pinestar Technology Inc

Primary DI
00850021301453
Brand
Pinestar Technology Inc
Company
PINESTAR TECHNOLOGY, INC.
Model
76-801
Device description
Flood Phantom
Published
2020-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IYQPhantom, Flood Source, Nuclear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYQPhantom, Flood Source, NuclearRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850021301453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850021301453008500213014538500213014530850021301453

GMDN Terms#

Term, Definition table
TermDefinition
Nuclear medicine phantom, flood sourceA device which is either a radioactive sealed source or a water-filled radiolucent disc or other shape to which radioactivity can be added. It is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of photon detector systems used in nuclear medicine applications and associated image acquisition, display, and analysis computer programs.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
037933645
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850021301415Pinestar Technology IncSC-1002020-07-24
00850021301354Pinestar Technology IncNMC-CASE2020-07-24
00850021301361Pinestar Technology IncNMC-PIL2020-07-24
00850021301484Pinestar Technology Inc2155-92152021-06-16
00850021301460Pinestar Technology IncNMC-768012020-09-28
00850021301477Pinestar Technology IncNMC-300U2020-09-24
00850021301439Pinestar Technology IncPTI-402-AFL2020-08-19
00850021301446Pinestar Technology IncPTI-408FPC2020-08-19
00850021301422Pinestar Technology IncNMC-2652020-08-13
00850021301033Pinestar Technology IncNMC-SSY2020-07-23
00850021301101Pinestar Technology IncCMDL-1071612020-07-24
00850021301026Pinestar Technology IncNMC-SAB2020-07-23
00850021301040Pinestar Technology Inc2149-27102020-07-23
00850021301057Pinestar Technology Inc2155-27102020-07-23
00850021301064Pinestar Technology Inc5200-35632020-07-23
00850021301071Pinestar Technology IncCLR-8052020-07-23
00850021301088Pinestar Technology IncCLR-8072020-07-23
00850021301095Pinestar Technology IncCLR-8102020-07-23
00850021301118Pinestar Technology IncCT-HH2020-07-23
00850021301125Pinestar Technology IncDAT-HH2020-07-23

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