Identity
- Trade Name
- TM "Rehabilitimed" GS-2 S Comfort FDA UDI
- Generic Name
- Ankle/foot orthosis FDA UDI
- Device Name
- It is a fabric shoe, without a toe and heel, made of a multilayer material with a high cotton content. Reinforced on the sides with four metal stiffening ribs, curved to the shape of the leg and covered with a special material for a comfortable fit of the orthosis to the bone protrusions of the joint. The orthosis is attached to the leg by textile fasteners, which allow you to adjust the pressure on the fabric and position the product on the leg with maximum comfort. Graphite color. FDA UDI
- Model / Reference
- GS-2 S Comfort FDA UDI
- Description
- It is a fabric shoe, without a toe and heel, made of a multilayer material with a high cotton content. Reinforced on the sides with four metal stiffening ribs, curved to the shape of the leg and covered with a special material for a comfortable fit of the orthosis to the bone protrusions of the joint. The orthosis is attached to the leg by textile fasteners, which allow you to adjust the pressure on the fabric and position the product on the leg with maximum comfort. Graphite color. FDA UDI
Identifiers
- Catalog Number
- GS-2 S Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097716922 FDA UDI
- FDA Product Code
- ITW FDA UDI
- GMDN Term
- Ankle/foot orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 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: Ankle/foot orthosis
TM "Rehabilitimed" GS-2 S 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 e1fe8ec2-f2d7-4773-951b-c74345fc1cff 36 fields · synced May 30, 2026