Identity
- Trade Name
- Trulife FDA UDI
- Generic Name
- External limb prosthesis finishing component, non-customized FDA UDI
- Device Name
- SEC2 Endoskeletal Cosmesis EUDAMEDCOSMETIC COVER 22-R SHORT FDA UDI
- Model / Reference
- SEC201-22R EUDAMEDFDA UDI
- Description
- COSMETIC COVER 22-R SHORT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00645517377520 EUDAMEDFDA UDI
- Basic UDI-DI
- 00645517CosmesisCG EUDAMED
- FDA Product Code
- ISH FDA UDI
- EMDN Code
- Y062499 LOWER EXTREMITY PROSTHESES - OTHER EUDAMED
- GMDN Term
- External limb prosthesis finishing component, non-customized FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3420 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: External limb prosthesis finishing component, non-customized
Trulife by Trulife, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Trulife, Inc.
Sources (2)
- FDA UDI 9b44cc44-cd29-497f-a9bd-8402df7b663d 33 fields · synced Sep 17, 2026
- EUDAMED 938dce18-a516-4655-ad1f-c00549eae877 61 fields · synced Sep 17, 2026