Identity
- Trade Name
- TM "Rehabilitimed" ORTEZ-2V-1 M-75 Comfort FDA UDI
- Generic Name
- Cervical spine collar, single-use FDA UDI
- Device Name
- It is an orthosis for the cervical spine in the form of an anatomically shaped base made of foamed polyethylene 75 mm high, which has the necessary density and elasticity, and a cover made of multilayer material (special velor triple-layered fabric (glued in a special way with polyurethane foam) with cotton terry cloth) of graphite color. On both sides of the orthosis, a textile fastener is sewn, which allows you to more accurately fix the product around the neck. FDA UDI
- Model / Reference
- ORTEZ-2V-1 M-75 Comfort FDA UDI
- Description
- It is an orthosis for the cervical spine in the form of an anatomically shaped base made of foamed polyethylene 75 mm high, which has the necessary density and elasticity, and a cover made of multilayer material (special velor triple-layered fabric (glued in a special way with polyurethane foam) with cotton terry cloth) of graphite color. On both sides of the orthosis, a textile fastener is sewn, which allows you to more accurately fix the product around the neck. FDA UDI
Identifiers
- Catalog Number
- ORTEZ-2V-1 M-75 Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097718216 FDA UDI
- FDA Product Code
- IQK FDA UDI
- GMDN Term
- Cervical spine collar, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3490 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cervical spine collar, single-use
TM "Rehabilitimed" ORTEZ-2V-1 M-75 Comfort by Reabilitimed Tov — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Reabilitimed Tov
Sources (1)
- FDA UDI c81316cc-ad97-4f1d-875e-0251d4cf1747 36 fields · synced May 30, 2026