FDA.reportPublic FDA data

Pinestar Technology Inc

Primary DI
00850021301064
Brand
Pinestar Technology Inc
Company
PINESTAR TECHNOLOGY, INC.
Model
5200-3563
Device description
Arm Boards
Published
2020-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NODBoard, Arm (With Cover), Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NODBoard, Arm (With Cover), Non-SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850021301064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850021301064008500213010648500213010640850021301064

GMDN Terms#

Term, Definition table
TermDefinition
Arm procedure positioner, reusableA preformed device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., orthopaedic surgery, anaesthesia administration, blood donation, intravenous (IV) infusion, physical therapy massage]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and is typically attached or fixed onto a side rail, operation/examination table, blood donor couch, or a chair, and has adjustable height, tilt, rotation, and lock positioning capabilities. This is a reusable device.

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
00850021301453Pinestar Technology Inc76-8012020-09-28
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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