Identity
- Trade Name
- Stratis FDA UDI
- Generic Name
- Meniscus screw FDA UDI
- Device Name
- ACL System Sterilization Tray FDA UDI
- Model / Reference
- 2064SS FDA UDI
- Description
- ACL System Sterilization Tray FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521513679 FDA UDI
- 510(k) Number
- K041749 FDA UDI
- FDA Product Code
- KMF FDA UDI
- GMDN Term
- Meniscus screw FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5090 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Stratis by Covidien LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K041749 also covers:
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
- Covidien LP
Sources (1)
- FDA UDI 2d48d229-176f-4f68-a95b-e6a794691649 36 fields · synced Jun 8, 2026