FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSEOUS Zoellner Suction Tube for Ear-Disposable
DI: 08904428723232
·
Model: EI1508100-Z
·
EON MEDITECH PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- OSSEOUS Zoellner Suction Tube for Ear-Disposable
- Primary DI
- 08904428723232
- Version / Model
- EI1508100-Z
- Company Name
- EON MEDITECH PRIVATE LIMITED
- Labeler DUNS
- 930270428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-04
- Public Version
- 1
- Public Version Date
- 2024-07-12
- Public Version Status
- New
- Public Device Record Key
- bb7f5e6b-911e-4d2e-b989-782eafee9a1c
Device Description
Suction Tubes for Ear Disposable are for suction of fluid and other media from the ear.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JZF | Tube, Ear Suction | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64240 | Ear canal suction handle | A noninvasive, non-powered, hand-held device intended to be connected to, and facilitate manipulation of, an appropriate cannula (not included) for suction/removal (aspiration) of debris from the ear canal during an ear/nose/throat (ENT) procedure; it is not intended for irrigation. It is in the form of a cylinder with an inner lumen which may incorporate a side-hole for low-level suction control (e.g., using the thumb); it does not incorporate a switch(es), valve(s) or button(s). It may include connection tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08904428747269 | GS1 | Laminated Box | 10 | In Commercial Distribution | |
| Primary | 08904428723232 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.8 | Millimeter | |
| Length | 100.0 | Millimeter | |
| Angle | 30 | degree |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius