FDA.reportPublic FDA data

Pinestar Technology Inc

Primary DI
00850021301125
Brand
Pinestar Technology Inc
Company
PINESTAR TECHNOLOGY, INC.
Model
DAT-HH
Device description
Imaging Head Support
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
IWYHolder, Head, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWYHolder, Head, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850021301125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850021301125008500213011258500213011250850021301125

GMDN Terms#

Term, Definition table
TermDefinition
Radiological headrestA non-sterile device intended to facilitate adequate positioning and immobilization of the patient's head and neck for reproducible positioning during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, cushion, or preformed pad that is intended to directly contact the head, and which may be customizable for single-patient use. 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
00850021301071Pinestar Technology IncCLR-8052020-07-23
00850021301088Pinestar Technology IncCLR-8072020-07-23
00850021301095Pinestar Technology IncCLR-8102020-07-23
00850021301118Pinestar Technology IncCT-HH2020-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640178061811pearltecPearl Technology AGIWY2025-07-28
04719879740615Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741179Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741186Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741193Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741209Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741216Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741223Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741230Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741247Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741162Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-11
04719879741285Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-10
04719879741261Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741278Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741292Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741308Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741315Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741322Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741339Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
00810004900622Neocis Guidance SystemNEOCIS INCIWY2025-05-02
00850043319146Head StabilizerHyperfine Operations, Inc.IWY2024-12-11
00810050245531NADOMICO MED-DEVICE, LLCIWY2024-06-21
06977071930014MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWY2024-06-21
06977071930069MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWY2024-06-21
00810050245487NADOMICO MED-DEVICE, LLCIWY2023-05-01
G242RHIAB9Techno-AideTechno-Aide, Inc.IWY2023-02-13
00850043319047Hyperfine Foam Head PadHyperfine Operations, Inc.IWY2023-01-25
00840326416037PanoramicYoung Innovations, Inc.IWY2023-01-05
00887761972872Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGIWY2023-01-05
00887761972889Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGIWY2023-01-05