Identity
- Trade Name
- OSSEOUS Suction Tube for Ear-Disposable FDA UDI
- Generic Name
- Ear canal suction handle FDA UDI
- Device Name
- Suction Tubes for Ear Disposable are for suction of fluid and other media from the ear. FDA UDI
- Model / Reference
- EI1504100 FDA UDI
- Description
- Suction Tubes for Ear Disposable are for suction of fluid and other media from the ear. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08904428724000 FDA UDI
- FDA Product Code
- JZF FDA UDI
- GMDN Term
- Ear canal suction handle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.4 Millimeter FDA UDILength — 100.0 Millimeter FDA UDIAngle — 30 degree FDA UDI
Category: Ear canal suction handle
OSSEOUS Suction Tube for Ear-Disposable by Eon Meditech Private Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ear canal suction handle.
- BR Surgical, LLC — BR SURGICAL LLC · Class I
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- FENTEX — FENTEX medical GmbH · Class I
- Lighted Suction — Bionix, LLC · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Sample, Lighted Suction Handle — Bionix, LLC · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- OSSEOUS Suction Tubes for Ear Disposable — EON MEDITECH PRIVATE LIMITED · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Eon Meditech Private Limited
Sources (1)
- FDA UDI 4c8a082f-172b-42fd-aa4c-ba45d123fc09 35 fields · synced May 30, 2026