← Back to catalogue

E³ MIS Pedicle Screw System

FDA UDI

Class I (US FDA UDI)

by Degen Medical

Identity

Trade Name
E³ MIS Pedicle Screw System FDA UDI
Generic Name
Orthopaedic counter-torque/rod-pushing instrument FDA UDI
Device Name
Counter Torque, Mini Tower Head FDA UDI
Model / Reference
06-37H FDA UDI
Description
Counter Torque, Mini Tower Head FDA UDI

Identifiers

Catalog Number
06-37H FDA UDI
Primary DI / UDI-DI
00842048153399 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic counter-torque/rod-pushing instrument FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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: Orthopaedic counter-torque/rod-pushing instrument

E³ MIS Pedicle Screw System by Degen Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic counter-torque/rod-pushing instrument.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Degen Medical

Sources (1)

  • FDA UDI 0756290f-5763-4669-a2ae-dfbe0891175f 35 fields · synced May 31, 2026