FDA Registration
Active
🇺🇸 United States
INVENTEX MEDICAL
Reg #: 3009495876
·
FEI: 3009495876
·
Expires 2026
Products
22
Proprietary Names
1
Establishment Types
2
Classifications
22
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Registration Details
- Registration Name
- INVENTEX MEDICAL
- Registration Number
- 3009495876
- FEI Number
- 3009495876
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 7415 N Melvina Ave
- City
- Niles
- State
- IL
- ZIP
- 60714
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213690
Owner / Operator
- Firm Name
- Inventex Medical
- Operator Number
- 10040210
- Address
- 7415 N. Melvina Av.
- City
- Niles
- State
- IL
- Postal Code
- 60714
- Country
- US
- Correspondent
- Steven R Amundson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2021-01-11 |
| Endoscopic Cholangiogram Kit | NWT | Class 2 | Gastroenterology, Urology | No | 2019-08-13 |
| Device, Anti-Snoring | LRK | Class 2 | Dental | No | 2021-05-18 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2018-05-29 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-04-07 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2020-02-27 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2023-03-06 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2020-12-17 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2021-01-21 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2013-01-24 |
| Retainer, Matrix | JEP | Class 1 | Dental | No | 2020-02-17 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2013-08-23 |
| Electrosurgical Patient Return Electrode | ODR | Class 2 | General, Plastic Surgery | No | 2013-08-23 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Catheter, Cholangiography | GBZ | Class 1 | General, Plastic Surgery | No | 2014-07-15 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2012-03-19 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2014-01-13 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2018-05-29 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2019-08-13 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2021-01-21 |
| Pneumoperitoneum Needle | FHO | Class 2 | Gastroenterology, Urology | No | 2019-12-12 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2019-12-12 |
Proprietary Names
ZQuiet
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)