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Honan Balloon With Press Valve

FDA UDI

Class II (US FDA UDI)

by Katena Products, Inc.

Identity

Trade Name
HONAN BALLOON WITH PRESS VALVE FDA UDI
Generic Name
Intraocular pressure-reducing compression system FDA UDI
Model / Reference
K 9-8410 FDA UDI

Identifiers

Catalog Number
K 9-8410 FDA UDI
Primary DI / UDI-DI
00841668112137 FDA UDI
510(k) Number
K820526 FDA UDI
FDA Product Code
LCC FDA UDI
GMDN Term
Intraocular pressure-reducing compression system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.4610 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Intraocular pressure-reducing compression system

Honan Balloon With Press Valve by Katena Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraocular pressure-reducing compression system.

Cleared under the same submission

K820526 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Katena Products, Inc.

Sources (1)

  • FDA UDI d46c77ef-4b85-420c-b040-acc45c83ab64 35 fields · synced Jun 12, 2026