FDA.reportPublic FDA data

PTEYE

Primary DI
00763000497163
Brand
PTEYE
Company
MEDTRONIC XOMED, INC.
Model
PTEYE-RF
Device description
CONSOLE PTEYE-RF REFURBISHED
Published
2023-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00763000497163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000497163007630004971637630004971630763000497163

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 Pressure500 millibar1060 millibar
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-29 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150064069ApexCut187BL40002026-04-25
00199150064076ApexCut187BL4000L2026-04-25
00199150064083ApexCut187BL40122026-04-25
00199150064090ApexCut187BL40402026-04-25
00199150064106ApexCut187BL40602026-04-25
00763000945640ApexCut187BL29002026-04-25
00763000945657ApexCut187BL35002026-04-25
00763000945718ApexCut187BL35122026-04-25
00763000945732ApexCut187BL35402026-04-25
00763000945756ApexCut187BL29602026-04-24
00763000945763ApexCut187BL35602026-04-25
00763000945787ApexCut187BL29752026-04-25
00763000945794ApexCut187BL35902026-04-25
00763000945800ApexCut187BL351202026-04-25
20643169782666NIM Trivantage®82297392016-11-12
20763000041544NIM TriVantage®82297392020-02-29
00763000033972NIM TriVantage®82297092020-02-15
20681490055158Merocel®22185352017-10-16
00643169782617NIM Trivantage®82297092016-11-12
00613994176547Reuter10103012015-07-07

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
00763000497040PTEYEMEDTRONIC XOMED, INC.QDF2023-09-16
00763000497057PTEYEMEDTRONIC XOMED, INC.QDF2023-06-24
00865124000431PTeye Parathyroid Detection SystemAiBiomedQDF2019-12-10
00865124000448PTeye Fiber Optic ProbeAiBiomedQDF2019-12-10