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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 surgical distractor, internal FDA UDI
Device Name
Compressor Distractor FDA UDI
Model / Reference
06-01S FDA UDI
Description
Compressor Distractor FDA UDI

Identifiers

Catalog Number
06-01S FDA UDI
Primary DI / UDI-DI
00842048153078 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic surgical distractor, internal 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 surgical distractor, internal

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 surgical distractor, internal.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Degen Medical

Sources (1)

  • FDA UDI c3cb1355-baf9-4b18-8585-f519692a2810 35 fields · synced May 31, 2026