Identity
- Trade Name
- STRADIS HEALTHCARE FDA UDI
- Generic Name
- Orthopaedic implant-instrument extension adaptor, single-use FDA UDI
- Model / Reference
- 570-3200 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M75257032000 FDA UDI
- FDA Product Code
- OJH FDA UDI
- GMDN Term
- Orthopaedic implant-instrument extension adaptor, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic implant-instrument extension adaptor, single-use
Stradis Healthcare by Stradis Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic implant-instrument extension adaptor, single-use.
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- Arthrex® — Arthrex, Inc. · Class I
- POWER ADAPTER — Biomet Orthopedics, Inc. · Class I
- Persona® — Zimmer, Inc. · 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
- Stradis Medical, Llc
Sources (1)
- FDA UDI 821e8320-6206-46f6-9a37-1482705a5b99 33 fields · synced May 30, 2026