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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
Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDI
Device Name
Sounder - Stiff FDA UDI
Model / Reference
06.0 FDA UDI
Description
Sounder - Stiff FDA UDI

Identifiers

Catalog Number
09.0727 FDA UDI
Primary DI / UDI-DI
00815500025497 FDA UDI
510(k) Number
K121786 FDA UDI
FDA Product Code
NKB FDA UDI
MNI FDA UDI
MNH FDA UDI
GMDN Term
Abdominal/ENT/orthopaedic surgical probe, reusable 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: Abdominal/ENT/orthopaedic surgical probe, reusable

Dymaxeon by Back 2 Basic Direct, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Abdominal/ENT/orthopaedic surgical probe, reusable.

Cleared under the same submission

K121786 also covers:

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 255b9b4e-1f78-4395-8855-088cbb08a48a 36 fields · synced May 30, 2026