Identity
- Trade Name
- Easy Mount™ Tub-Rail 1 Pack FDA UDI
- Generic Name
- Bath hand rail FDA UDI
- Device Name
- The Tub-Rail is a high quality tub mounted grab bar that clamps onto a bathtub threshold. The Tub-Rail is intended for moderate vertical load bearing to provide sitting and standing support for people with reduced mobility. The clamping mechanism is a stainless steel threaded rod that, when tightened, pulls an articulating clamp plate against the bathtub threshold to provide force strong enough to support the user. The maximum user weight for this product is 300lbs / 136kgs. Not to be used on fiberglass bathtubs. Note: Product is not intended to support full body weight. FDA UDI
- Model / Reference
- TBR-S FDA UDI
- Description
- The Tub-Rail is a high quality tub mounted grab bar that clamps onto a bathtub threshold. The Tub-Rail is intended for moderate vertical load bearing to provide sitting and standing support for people with reduced mobility. The clamping mechanism is a stainless steel threaded rod that, when tightened, pulls an articulating clamp plate against the bathtub threshold to provide force strong enough to support the user. The maximum user weight for this product is 300lbs / 136kgs. Not to be used on fiberglass bathtubs. Note: Product is not intended to support full body weight. FDA UDI
Identifiers
- Catalog Number
- 03383 FDA UDI
- Primary DI / UDI-DI
- 00689281033831 FDA UDI
- FDA Product Code
- IKX FDA UDI
- GMDN Term
- Bath hand rail FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bath hand rail
Easy Mount™ Tub-Rail 1 Pack by Healthcraft Products Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Healthcraft Products Inc.
Sources (1)
- FDA UDI 8be108d7-243d-437d-b398-db2935d54276 34 fields · synced Jun 8, 2026