FDA.reportPublic FDA data

PTeye Fiber Optic Probe

Primary DI
00865124000448
Brand
PTeye Fiber Optic Probe
Company
AiBiomed
Model
PTeye-1
Device description
Fiber Optic Probe. Single Use. Sterile. 1 unit per package.
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
Sterile
true
Single use
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
00865124000448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865124000448008651240004488651240004480865124000448

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative parathyroid detection system probeA sterile hand-held 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. The probe consists of a fibreoptic element that emits non-ionizing radiation in the near IR range (NIR), and another fibreoptic detector element for collection and transmission of the fluorescence emitted by the tissue to a photo detector. It is used with a dedicated control unit (not included). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079623223
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00865124000431PTeye Parathyroid Detection SystemPTeye2019-12-10

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
00865124000431PTeye Parathyroid Detection SystemAiBiomedQDF2019-12-10