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PENTAX Medical

FDA UDI

Class II (US FDA UDI)

by Hoya Corporation

Identity

Trade Name
PENTAX Medical FDA UDI
Generic Name
Endoscope video camera FDA UDI
Device Name
PENTAX Medical Camera Head PVK-J10 FDA UDI
Model / Reference
PVK-J10 FDA UDI
Description
PENTAX Medical Camera Head PVK-J10 FDA UDI

Identifiers

Primary DI / UDI-DI
04961333253890 FDA UDI
510(k) Number
K220465 FDA UDI
FDA Product Code
EOB FDA UDI
EQL FDA UDI
OUG FDA UDI
PEA FDA UDI
GMDN Term
Endoscope video camera FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4760 FDA UDI
874.4750 FDA UDI
880.6310 FDA UDI
876.1500 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: Endoscope video camera

PENTAX Medical by Hoya Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscope video camera.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hoya Corporation

Sources (1)

  • FDA UDI 8f0a5221-5f85-42b7-9397-7679ab626cf1 34 fields · synced May 31, 2026