Identity
- Trade Name
- De Mayo Ankle Distractor™ FDA UDI
- Generic Name
- Orthopaedic surgical distractor, external FDA UDI
- Device Name
- 1109 Sawbones base & bridge FDA UDI
- Model / Reference
- 1109 SAWBONES FDA UDI
- Description
- 1109 Sawbones base & bridge FDA UDI
Identifiers
- Catalog Number
- 1109 SAWBONES FDA UDI
- Primary DI / UDI-DI
- 00696588003900 FDA UDI
- FDA Product Code
- FWZ FDA UDI
- GMDN Term
- Orthopaedic surgical distractor, external FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4950 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
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
Moist Heat or Steam Sterilization FDA UDI
De Mayo Ankle Distractor™ by Innovative Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Innovative Medical Products, Inc.
Sources (1)
- FDA UDI 670c9649-64e0-433d-b281-566a499913f5 35 fields · synced Jun 1, 2026