Identity
- Trade Name
- HONAN BALLOON HEADBAND (NO LATEX) FDA UDI
- Generic Name
- Intraocular pressure-reducing compression system FDA UDI
- Model / Reference
- K 9-8412 FDA UDI
Identifiers
- Catalog Number
- K 9-8412 FDA UDI
- Primary DI / UDI-DI
- 00841668112151 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
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
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 Headband (no Latex) 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.
- Honan Intraocular Pressure Reducer — LEBANON CORP, THE · Class II
- Honan Intraocular Pressure Reducer — LEBANON CORP, THE · Class II
- JEDMED — JEDMED Instrument Company · Class II
- Honan Intraocular Pressure Reducer — LEBANON CORP, THE · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- Honan Intraocular Pressure Reducer — LEBANON CORP, THE · Class II
- Honan Intraocular Pressure Reducer — LEBANON CORP, THE · Class II
Cleared under the same submission
K820526 also covers:
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Katena Products, Inc.
Sources (1)
- FDA UDI e8c3a956-b621-4616-8a83-a5f2392c461b 35 fields · synced Jun 12, 2026