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MatrixMANDIBLE

FDA UDI

Class I (US FDA UDI)

by Synthes

Identity

Trade Name
MatrixMANDIBLE FDA UDI
Generic Name
Surgical instrument/implant rack FDA UDI
Device Name
LAG SCREW MODULE MATRIXMANDIBLE SYSTEM FDA UDI
Model / Reference
306.755 FDA UDI
Description
LAG SCREW MODULE MATRIXMANDIBLE SYSTEM FDA UDI

Identifiers

Catalog Number
306755 FDA UDI
Primary DI / UDI-DI
10887587034430 FDA UDI
FDA Product Code
FSM FDA UDI
GMDN Term
Surgical instrument/implant rack FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical instrument/implant rack

MatrixMANDIBLE by Synthes — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument/implant rack.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synthes

Sources (1)

  • FDA UDI ea8ac2c2-e1eb-4398-8990-26e3bcd34630 35 fields · synced May 31, 2026