Identity
- Trade Name
- JEDMED FDA UDI
- Generic Name
- Intraocular pressure-reducing compression system FDA UDI
- Device Name
- REPLACEMENT HEADBAND F/OPD FDA UDI
- Model / Reference
- 29-0460 FDA UDI
- Description
- REPLACEMENT HEADBAND F/OPD FDA UDI
Identifiers
- Catalog Number
- 29-0460 FDA UDI
- Primary DI / UDI-DI
- M6332904600 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intraocular pressure-reducing compression system
Jedmed by JEDMED Instrument Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraocular pressure-reducing compression system.
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- Ambler Surgical — Ambler Surgical, LLC · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- Honan Intraocular Pressure Reducer — LEBANON CORP, THE · Class II
- HONAN BALLOON HEADBAND (NO LATEX) — Katena Products, Inc. · Class II
- Honan Intraocular Pressure Reducer — LEBANON CORP, THE · Class II
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 |
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Manufacturer
- Manufacturer
- JEDMED Instrument Company
Sources (1)
- FDA UDI 7bfc3831-d22d-44a1-a265-0c0d28e68223 34 fields · synced May 30, 2026