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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 surgical distractor, internal FDA UDI
Device Name
Distractor - 5.5mm FDA UDI
Model / Reference
05.5 FDA UDI
Description
Distractor - 5.5mm FDA UDI

Identifiers

Catalog Number
09.0666 FDA UDI
Primary DI / UDI-DI
00815500023493 FDA UDI
FDA Product Code
NKB FDA UDI
MNI FDA UDI
MNH FDA UDI
GMDN Term
Orthopaedic surgical distractor, internal 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 surgical distractor, internal

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 surgical distractor, internal.

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 a9327a49-6b79-4088-8b06-d05be6a34e9a 35 fields · synced Jun 8, 2026