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Tritium® Sternal Cable Plate System

FDA UDI

Class II (US FDA UDI)

by Pioneer Surgical Technology, Inc.

Identity

Trade Name
Tritium® Sternal Cable Plate System FDA UDI
Generic Name
Sternal fixation device FDA UDI
Device Name
Screw Driver FDA UDI
Model / Reference
86-DRIVER-2 FDA UDI
Description
Screw Driver FDA UDI

Identifiers

Catalog Number
86-DRIVER-2 FDA UDI
Primary DI / UDI-DI
00846468053901 FDA UDI
FDA Product Code
HWC FDA UDI
HRS FDA UDI
JDQ FDA UDI
GMDN Term
Sternal fixation device FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
888.3030 FDA UDI
888.3010 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Tritium® Sternal Cable Plate System by Pioneer Surgical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pioneer Surgical Technology, Inc.

Sources (1)

  • FDA UDI 3b0a2cb8-cfa5-420d-b0c4-308a93baa845 36 fields · synced Jun 1, 2026