Identity
- Trade Name
- Definition FDA UDI
- Generic Name
- Polymer orthopaedic cement restrictor, non-bioabsorbable FDA UDI
- Device Name
- Distal Centralizer FDA UDI
- Model / Reference
- 6265-4-010 FDA UDI
- Description
- Distal Centralizer FDA UDI
Identifiers
- Catalog Number
- 6265-4-010 FDA UDI
- Primary DI / UDI-DI
- 07613327035865 FDA UDI
- FDA Product Code
- MAY FDA UDIJDI FDA UDIKWY FDA UDIKWL FDA UDILZO FDA UDIMBL FDA UDILPH FDA UDILWJ FDA UDIKWZ FDA UDIMEH FDA UDI
- GMDN Term
- Polymer orthopaedic cement restrictor, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3350 FDA UDI888.3390 FDA UDI888.3360 FDA UDI888.3358 FDA UDI888.3310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Polymer orthopaedic cement restrictor, non-bioabsorbable
Definition is a non-bioabsorbable, implantable device designed to prevent cement progression in the diaphysis of long bones during orthopaedic surgery. It features a variety of designs and may incorporate metal orientation markers for radiographs, making it suitable for use in multiple applications including femur, tibia, and humerus.
Similar devices
Also classified as Polymer orthopaedic cement restrictor, non-bioabsorbable.
- Cement Plug — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- MectaPlug PE II — Medacta International · Class II
- Cement Plug — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- BUCK — Smith & Nephew, Inc. · Class II
- Signature Cement Plug — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- INTRAMEDULLARY BONE PLUG — Biomet Orthopedics, Inc. · Class II
- OrthoMedFlex — ORTHOMEDFLEX LLC · Class II
- BIO PLUG — Biomet Orthopedics, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Howmedica Osteonics Corp.
Sources (1)
- FDA UDI e1ac694e-0248-4fcb-b554-53bfcde2f979 35 fields · synced Jul 29, 2026