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Dymaxeon

FDA UDI

Class II (US FDA UDI)

by Back 2 Basic Direct, Llc

Identity

Trade Name
Dymaxeon FDA UDI
Generic Name
Orthopaedic counter-torque/rod-pushing instrument FDA UDI
Device Name
Counter torque with comfort handle FDA UDI
Model / Reference
05.5 FDA UDI
Description
Counter torque with comfort handle FDA UDI

Identifiers

Catalog Number
09.0685 FDA UDI
Primary DI / UDI-DI
00815500025558 FDA UDI
FDA Product Code
NKB FDA UDI
MNI FDA UDI
MNH FDA UDI
GMDN Term
Orthopaedic counter-torque/rod-pushing instrument FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 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

No

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
MRI Safety
MR Conditional FDA UDI

Category: Orthopaedic counter-torque/rod-pushing instrument

Dymaxeon by Back 2 Basic Direct, Llc — Class II — 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

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Manufacturer

Manufacturer
Back 2 Basic Direct, Llc

Sources (1)

  • FDA UDI d46d3a28-d8b4-44e4-991d-bcdf0931d5dd 35 fields · synced May 30, 2026