Identity
- Trade Name
- Respiratory Belt FDA UDI
- Generic Name
- Radiological whole-body positioner FDA UDI
- Device Name
- Respiratory Belt FDA UDI
- Model / Reference
- MTSBRT004 FDA UDI
- Description
- Respiratory Belt FDA UDI
Identifiers
- Catalog Number
- MTSBRT004 FDA UDI
- Primary DI / UDI-DI
- 00841439107263 FDA UDI
- 510(k) Number
- K153026 FDA UDI
- FDA Product Code
- IYE FDA UDILNH FDA UDI
- GMDN Term
- Radiological whole-body positioner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI892.1000 FDA UDI
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 87 Centimeter FDA UDI
Respiratory Belt by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 II | Pending data |
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Manufacturer
- Manufacturer
- Medtec LLC
Sources (1)
- FDA UDI 183ab0f7-4a57-4e85-b3cd-7506f8e5e662 38 fields · synced May 31, 2026