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Steady Step
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 50202Model Small/Medium Left
Identity
- Trade Name
- TOE HOLD® EUDAMEDSteady Step FDA UDI
- Generic Name
- Toe intraoperative aligner FDA UDI
- Device Name
- STEADY STEP® TOE HOLD® EUDAMEDSteady Step® Toehold® FDA UDI
- Model / Reference
- 50202 EUDAMEDFDA UDISmall/Medium Left EUDAMED
- Description
- Steady Step® Toehold® FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821615020296 EUDAMED00082161502029 FDA UDI
- Basic UDI-DI
- 082161STSTTHCA EUDAMED
- FDA Product Code
- ISH FDA UDI
- EMDN Code
- M0304010101 ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, LOW EXTENSIBILITY (<70%) EUDAMED
- GMDN Term
- Toe intraoperative aligner FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3420 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Toe intraoperative aligner
Steady Step by Brownmed, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Toe intraoperative aligner.
- Steady Step — BROWNMED, INC. · Class I
- Steady Step — BROWNMED, INC. · Class I
- Steady Step — BROWNMED, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brownmed, Inc.
Sources (2)
- FDA UDI c67a17c7-f570-4e16-8ded-1fd2d5cf98bc 33 fields · synced Jul 28, 2026
- EUDAMED f2aae141-c72b-43c8-bdba-e504adaf6311 61 fields · synced Jul 28, 2026