FDA.reportPublic FDA data

PTeye Parathyroid Detection System

Primary DI
00865124000431
Brand
PTeye Parathyroid Detection System
Company
AiBiomed
Model
PTeye
Device description
PTeye Console.
Published
2019-12-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QDFParathyroid Autofluorescence Detection Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDFParathyroid Autofluorescence Detection DeviceGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN170056000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170056000Parathyroid Detection (Model PTeye) SystemAibiomed, Corp.2018-11-02QDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865124000431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865124000431008651240004318651240004310865124000431

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative parathyroid detection system control unitAn electrically-powered component of an intraoperative parathyroid detection system designed to aid surgeons in recognizing parathyroid tissue during open surgical thyroidectomies and parathyroidectomies using near-infrared (NIR) light and auto-fluorescence. It consists of a console with display and controls. The NIR light is emitted, and the florescence measured, using a single-use invasive probe (not included).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-29 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079623223
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00865124000448PTeye Fiber Optic ProbePTeye-12019-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000849573PTEYE Parathyroid Detection SystemMEDTRONIC XOMED, INC.QDF2024-04-04
00763000849580PTEYE Parathyroid Detection SystemMEDTRONIC XOMED, INC.QDF2024-04-04
00763000497163PTEYEMEDTRONIC XOMED, INC.QDF2023-11-27
00763000497040PTEYEMEDTRONIC XOMED, INC.QDF2023-09-16
00763000497057PTEYEMEDTRONIC XOMED, INC.QDF2023-06-24
00865124000448PTeye Fiber Optic ProbeAiBiomedQDF2019-12-10