FDA Registration
Active
🇺🇸 United States
MEDICAL DISPOSABLES CORP
Reg #: 3009212837
·
FEI: 3009212837
·
Expires 2026
Products
26
Proprietary Names
8
Establishment Types
3
Classifications
26
Registration Details
- Registration Name
- MEDICAL DISPOSABLES CORP
- Registration Number
- 3009212837
- FEI Number
- 3009212837
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6831 Edgewater Commerce Pkwy, Ste 1101
- City
- Orlando
- State
- FL
- ZIP
- 32810
- Country
- US
Regulatory Submissions
- 510(k) Number
- K142208
Owner / Operator
- Firm Name
- Medical Disposables Corp
- Operator Number
- 10055555
- Address
- 6831 Edgewater Commerce Pkwy, Ste 1101
- City
- Orlando
- State
- FL
- Postal Code
- 32810
- Country
- US
- Correspondent
- Ralph Hernandez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-08-10 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-08-10 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2019-09-05 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2019-09-05 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2023-08-10 |
| Pneumoperitoneum Needle | FHO | Class 2 | Gastroenterology, Urology | No | 2023-08-10 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2019-09-05 |
Proprietary Names
EndoGuidance Monopolar Laparascopic Accessories
EndoGuidance Suction Irrigation System
MD DrugScreen Test
EndoGuidance Specimen Retrieval Bag
MD SalivaScreen
EndoGuidance Veress Needle
MD DrugScreen Test Cup
EndoGuidance Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Troca
Establishment Types
Repack or Relabel Medical Device
Manufacture Device in the United States for Export Only
Complaint File Establishment per 21 CFR 820.198