Identity
- Trade Name
- LEVEL ONE THORACIC, STERILE FDA UDI
- Generic Name
- Sternal fixation device FDA UDI
- Device Name
- PLATE, STERNAL, LOCKING, ANGLE, 2.3 MM SCREW, CP TITANIUM FDA UDI
- Model / Reference
- 24-025-59-71 FDA UDI
- Description
- PLATE, STERNAL, LOCKING, ANGLE, 2.3 MM SCREW, CP TITANIUM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888118146830 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Sternal fixation device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sternal fixation device
Level One Thoracic, Sterile by KLS-Martin L.P. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sternal fixation device.
- STERNALOCK® BLU SYSTEM — BIOMET MICROFIXATION, INC · Class II
- Vanguard® — Biomet Orthopedics, Inc. · Class I
- ARIX Sternal System Bone Screw — Jeil Medical Corporation · Class II
- ARIX Sternal System Bone Plate — Jeil Medical Corporation · Class II
- SternaFuse® Fixation System — FUSION INNOVATIONS · Class II
- Valkyrie Thoracic Fixation System — J.M. Longyear Manufacturing, LLC · Class II
- STERNALOCK® BLU SYSTEM — BIOMET MICROFIXATION, INC · Class II
- Valkyrie Thoracic Fixation System — J.M. Longyear Manufacturing, LLC · 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
- KLS-Martin L.P.
Sources (1)
- FDA UDI 1d63b8ff-9054-4596-9f9f-ef7e881192e8 35 fields · synced Jun 7, 2026