Identity
- Trade Name
- MatrixMANDIBLE FDA UDI
- Generic Name
- Manual orthopaedic bender, reusable FDA UDI
- Device Name
- MATRIXMANDIBLE PLATE BENDING IRON-LEFT FDA UDI
- Model / Reference
- SD300.104 FDA UDI
- Description
- MATRIXMANDIBLE PLATE BENDING IRON-LEFT FDA UDI
Identifiers
- Catalog Number
- SD300104 FDA UDI
- Primary DI / UDI-DI
- 10887587001609 FDA UDI
- FDA Product Code
- HXP FDA UDI
- GMDN Term
- Manual orthopaedic bender, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MatrixMANDIBLE by Synthes (u.s.a.) Lp — 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
- Synthes (u.s.a.) Lp
Sources (1)
- FDA UDI dd997457-5e5e-45bb-82e2-e4337e71089b 36 fields · synced May 31, 2026