GREYSTONE MEDICAL, LLC

FDA Device Registration & Listing · Waterford, MI, US · Registration 3015176887

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015176887
FEI Number
3015176887
Entity Name
GREYSTONE MEDICAL, LLC
City/State/Country
Waterford, MI, US
Establishment Address
7433 Pine Creek Trail Suite#B, Waterford, MI 48327, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Greystone Medical, LLC (Owner Number: 10058460)
Owner / Operator Contact Address
7433 Pine Creek Trail, Suite #B, Waterford, MI 48327, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Greystone Medical -BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) Gastroenterology, Urology Class 2 876.5130 2020-02-20
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2022-03-14
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2019-01-20
FAQ Bag, Urine Collection, Leg, For External Use, Sterile Gastroenterology, Urology Class 1 876.5250 2021-04-07
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2020-02-20
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2020-02-20
FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) Gastroenterology, Urology Class 2 876.5130 2019-07-19
KMJ Lubricant, Patient General Hospital Class 1 880.6375 2020-02-20

Official Correspondent

Kwamina Beecham

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Greystone Medical, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K233013 Silq Technologies Corporation 2-Way 100% Silicone Cleartract Catheter 2024-01-23
K820587 Abco Dealers, Inc. WET PACK LINE OF PRODUCTS 1982-03-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2013 Cure Medical LLC 2
Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.

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3006082230 C.R. BARD, INC. MADISON, GA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015176887. Last updated year: 2026. Please use registration number 3015176887 when referencing this establishment in official correspondence.
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