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PTeye Parathyroid Detection System

FDA UDI

Class II (US FDA UDI)

by Aibiomed, Corp.

Identity

Trade Name
PTeye Parathyroid Detection System FDA UDI
Generic Name
Intraoperative parathyroid detection system control unit FDA UDI
Device Name
PTeye Console. FDA UDI
Model / Reference
PTeye FDA UDI
Description
PTeye Console. FDA UDI

Identifiers

Primary DI / UDI-DI
00865124000431 FDA UDI
510(k) Number
DEN170056 FDA UDI
FDA Product Code
QDF FDA UDI
GMDN Term
Intraoperative parathyroid detection system control unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4550 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intraoperative parathyroid detection system control unit

PTeye Parathyroid Detection System by Aibiomed, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraoperative parathyroid detection system control unit.

Cleared under the same submission

DEN170056 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aibiomed, Corp.

Sources (1)

  • FDA UDI bf9d04fc-a595-400f-8c87-0f408fc46f3f 35 fields · synced Jun 8, 2026