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Pentax

FDA UDI

Class II (US FDA UDI)

by Hoya Corporation

Identity

Trade Name
PENTAX FDA UDI
Generic Name
Ultrasound endoscope balloon, synthetic polymer FDA UDI
Device Name
PENTAX Balloon OE-A52 FDA UDI
Model / Reference
OE-A52 FDA UDI
Description
PENTAX Balloon OE-A52 FDA UDI

Identifiers

Primary DI / UDI-DI
04961333253913 FDA UDI
FDA Product Code
EOQ FDA UDI
GMDN Term
Ultrasound endoscope balloon, synthetic polymer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4680 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ultrasound endoscope balloon, synthetic polymer

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

Similar devices

Also classified as Ultrasound endoscope balloon, synthetic polymer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hoya Corporation

Sources (1)

  • FDA UDI a20abbec-885b-41d4-9a8b-d343239a78a6 33 fields · synced May 31, 2026