Identity
- Trade Name
- PENDING FDA UDI
- Generic Name
- Orthodontic anchor plate FDA UDI
- Device Name
- SCREW, CANCELLOUS, 4.0 X 16MM FDA UDI
- Model / Reference
- MPSC4016 FDA UDI
- Description
- SCREW, CANCELLOUS, 4.0 X 16MM FDA UDI
Identifiers
- Catalog Number
- MPSC4016 FDA UDI
- Primary DI / UDI-DI
- 10080196015528 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthodontic anchor plate FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
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
MR Unsafe FDA UDI
Category: Orthodontic anchor plate
Pending by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic anchor plate.
- LEVEL ONE ORTHOANCHOR — KLS-Martin L.P. · Class II
- LEVEL ONE ORTHOANCHOR — KLS-Martin L.P. · Class II
- LEVEL ONE ORTHOANCHOR — KLS-Martin L.P. · Class II
- MATRIXWAVE — Synthes · Class II
- NEOFACE — Neoortho Produtos Ortopédicos S/A. · Class II
- LEVEL ONE ORTHOANCHOR — KLS-Martin L.P. · Class II
- GBR System Bone Plate — Jeil Medical Corporation · Class II
- GBR System Bone Plate — Jeil Medical Corporation · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI 11868e82-efb8-4736-b2b3-16efc3caa003 35 fields · synced Jun 6, 2026