Identity
- Trade Name
- Trulife FDA UDI
- Generic Name
- Thoracic spine orthosis FDA UDI
- Device Name
- Spinal Orthosis EUDAMEDARTICULATING HYPEREXTENSION BRACE SM-MD SHORT FDA UDI
- Model / Reference
- T39S-02 EUDAMEDFDA UDI
- Description
- ARTICULATING HYPEREXTENSION BRACE SM-MD SHORT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00645517857589 EUDAMEDFDA UDI
- Basic UDI-DI
- 00645517Spinal93 EUDAMED
- FDA Product Code
- MRI FDA UDI
- EMDN Code
- Y060399 SPINE ORTHOSES - OTHER EUDAMED
- GMDN Term
- Thoracic spine orthosis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3490 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Category: Thoracic spine orthosis
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
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
- Trulife, Inc.
Sources (2)
- FDA UDI 199b36be-94b5-4c39-9f74-f10e88eb995b 33 fields · synced Jul 8, 2026
- EUDAMED 391f50d7-00cd-43e2-8c39-acbbc6d97d12 61 fields · synced Jul 8, 2026