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Sign in to claim this brandSterigear, LLC
US
Last updated May 30, 2026
What Sterigear, LLC makes
Sterigear, LLC manufactures urine management products for adults, including non‑wearable open‑ended urine collection bags, wearable open‑ended urine collection bags, and intermittent urethral catheterization kits. All of these devices are marketed under the SteriGear name and are intended for use in clinical or home settings to collect and manage urine output.
The company's product portfolio is classified as Class II medical devices and each device is recorded in the FDA UDI database. Sterigear, LLC is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of urine management products does Sterigear, LLC manufacture?
Sterigear, LLC produces three main categories of adult urine management products: non‑wearable open‑ended urine collection bags, wearable open‑ended urine collection bags, and intermittent urethral catheterization kits. These are all marketed under the SteriGear brand and are intended for clinical or home use to collect and manage urine output.
Where is Sterigear, LLC located and which regulatory listing includes its devices?
The company is based in the United States. All of its urine management devices are recorded in the FDA UDI (Unique Device Identifier) database, which is the regulatory listing that documents each device’s identifier and classification.
How are Sterigear’s devices classified under FDA regulations?
Each of Sterigear’s urine management products is classified as a Class II medical device. This classification reflects that the devices present moderate risk and are subject to specific regulatory controls, such as performance standards and post‑market surveillance, as defined by the FDA.
Are Sterigear’s products approved or cleared by the FDA?
The company’s devices are not themselves approved; rather, each individual product must obtain FDA authorization before it can be marketed. Sterigear’s devices are listed in the FDA UDI database, indicating that they have undergone the necessary regulatory processes for their specific classifications.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- propellerinc.com
- —
- —
- [email protected]
- Phone
- +1(800)398-3259
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 809509297
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SteriGear | UE4001-00 | FDA UDI | Class II | Active |
| SteriGear | UE4001-00 | FDA UDI | Class II | Active |
| SteriGear | A4092-81 | FDA UDI | Class II | Active |
| SteriGear | UE4001-00 | FDA UDI | Class II | Active |
| SteriGear | REA4094-01 | FDA UDI | N/A | Active |
| SteriGear | REA4001-01 | FDA UDI | Class II | Active |
| SteriGear | RE4068P-01 | FDA UDI | N/A | Active |
| SteriGear | UE4001-00 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Sterigear, LLC has one FDA recall record initiated on 2011-01-11, which is marked as terminated. The recall pertains to the The Fig Leaf urinary drain bag, where the manufacturer notified customers of circumstances in which the valve could close and create negative pressure, potentially affecting the non-return valve.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 11, 2011 | Z-1848-2014 | — | terminated | SteriGear notifed customers of circumstances in which The Fig Leaf urinary drain bag valve can close creating a negative pressure that can suck the non-return valve closed. |