Identity
- Trade Name
- SACH Foot for Children FDA UDI
- Generic Name
- Mechanical-resistance external ankle-foot prosthesis FDA UDI
- Device Name
- SACH Foot for Children with Split Toe, size: 16 cm, side: left, weight: 110 g, height: 51 mm, thread M8, max. body weight: 35 kg FDA UDI
- Model / Reference
- 30A26/16L FDA UDI
- Description
- SACH Foot for Children with Split Toe, size: 16 cm, side: left, weight: 110 g, height: 51 mm, thread M8, max. body weight: 35 kg FDA UDI
Identifiers
- Catalog Number
- 30A26/16L FDA UDI
- Primary DI / UDI-DI
- 04048817485227 FDA UDI
- FDA Product Code
- ISH FDA UDI
- GMDN Term
- Mechanical-resistance external ankle-foot prosthesis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3420 FDA UDI
- Commercial Distribution
- 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mechanical-resistance external ankle-foot prosthesis
SACH Foot for Children by Streifeneder ortho.production GmbH — 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
- Streifeneder ortho.production GmbH
Sources (1)
- FDA UDI cea3b665-8e2d-4fbd-ae86-a72d38cdd258 35 fields · synced May 30, 2026