FDA Registration
Active
🇺🇸 United States
GREYSTONE MEDICAL, LLC
Reg #: 3015176887
·
FEI: 3015176887
·
Expires 2026
Products
9
Proprietary Names
3
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- GREYSTONE MEDICAL, LLC
- Registration Number
- 3015176887
- FEI Number
- 3015176887
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 7433 Pine Creek Trail Suite#B
- City
- Waterford
- State
- MI
- ZIP
- 48327
- Country
- US
Regulatory Submissions
- 510(k) Number
- K030664
Owner / Operator
- Firm Name
- Greystone Medical, LLC
- Operator Number
- 10058460
- Address
- 7433 Pine Creek Trail, Suite #B
- City
- Waterford
- State
- MI
- Postal Code
- 48327
- Country
- US
- Correspondent
- Kwamina B Beecham
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | Class 2 | Gastroenterology, Urology | No | 2020-02-20 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2022-03-14 |
| Catheter, Straight | EZD | Class 2 | Gastroenterology, Urology | No | 2019-01-20 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2021-04-07 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2020-02-20 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2020-02-20 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2021-04-07 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2021-04-07 |
| Catheter, Urethral | GBM | Class 2 | Gastroenterology, Urology | No | 2024-01-24 |
Proprietary Names
Greystone Medical -BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE
Greystone Medical -COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
GREYSTONE HYDROPHILIC URETHRAL CATHETER- JAW [Just Add Water]
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device