FDA.reportPublic FDA data

Pinestar Technology Inc

Primary DI
00850021301071
Brand
Pinestar Technology Inc
Company
PINESTAR TECHNOLOGY, INC.
Model
CLR-805
Device description
"Comfort Leg Rest, 5"" High"
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
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850021301071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850021301071008500213010718500213010710850021301071

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, reusableA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). 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
00850021301064Pinestar Technology Inc5200-35632020-07-23
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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Primary DI, Brand, Company table
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00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCCCX2026-05-31
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10197344149834MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-22
10197344149803MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
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