Identity
- Trade Name
- BMI FDA UDI
- Generic Name
- Hip orthosis FDA UDI
- Device Name
- Hip/Knee Orthosis, size Small FDA UDI
- Model / Reference
- HKO-S FDA UDI
- Description
- Hip/Knee Orthosis, size Small FDA UDI
Identifiers
- Catalog Number
- HKO-S FDA UDI
- Primary DI / UDI-DI
- G088HKOS0 FDA UDI
- FDA Product Code
- IOZ FDA UDI
- GMDN Term
- Hip orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3665 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
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: Hip orthosis
Bmi by Blake Manufacturing, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hip orthosis.
- MECRON Hip-Spica U: 95-115 cm — Darco (Europe) GmbH · Class I
- MECRON Hip-Spica U: 95-115 cm — Darco (Europe) GmbH · Class I
- MECRON Hip-Compression U: 105-125 cm — Darco (Europe) GmbH · Class I
- ManaMed Inc — MANAMED LLC · Class I
- Vive — VIVE HEALTH LLC · Class I
- Vive — VIVE HEALTH LLC · Class I
- MECRON Hip-Compression U: 105-125 cm — Darco (Europe) GmbH · Class I
- MECRON Hip-Spica U: 95-115 cm — Darco (Europe) GmbH · Class I
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
- Blake Manufacturing, Inc.
Sources (1)
- FDA UDI bc3cb414-ce6b-4271-86ce-2b9300e7bf03 34 fields · synced May 30, 2026