FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Hearing Lab
DI: 05056100709492
·
Model: LAB-2014P
·
NETWORK MEDICAL PRODUCTS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Hearing Lab
- Primary DI
- 05056100709492
- Version / Model
- LAB-2014P
- Company Name
- NETWORK MEDICAL PRODUCTS LIMITED
- Labeler DUNS
- 458670304
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2021-07-13
- Public Version
- 2
- Public Version Date
- 2023-01-05
- Public Version Status
- Update
- Public Device Record Key
- 83398a02-ed2d-4ec0-b2c4-da03e79ee6f5
- Distribution End Date
- 2023-01-04
Device Description
"Suction Tube - Zoellner 'Pen -Grip' Type 2mm x 85mm / Distal Bend / Acute 30° Angle / With Suction Control"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| 35917 | Surgical/emergency suction cannula, non-illuminating, single-use | An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 05056100709508 | GS1 | ||||
| Primary | 05056100709492 | GS1 |