← Back to catalogue

Pro-Dex CMF Surgical Driver (AXS™ NEURO DRIVER)

FDA UDIEUDAMED

Class I (US FDA UDI)

by Pro-Dex, Inc.

Identity

Trade Name
Pro-Dex CMF Surgical Driver (AXS™ NEURO DRIVER) FDA UDI
Generic Name
Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
Model / Reference
PDCMF-1000-1 FDA UDI

Identifiers

Primary DI / UDI-DI
00856482008252 FDA UDI
FDA Product Code
GEY FDA UDI
GXL FDA UDI
GMDN Term
Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 FDA UDI
882.4900 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone/joint surgical power tool motorized handpiece/set, electric, reusable

Pro-Dex CMF Surgical Driver (AXS™ NEURO DRIVER) by Pro-Dex, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Bone/joint surgical power tool motorized handpiece/set, electric, reusable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Pro-Dex, Inc.

Sources (2)

  • FDA UDI 4436f50b-cafe-4b84-beaa-5ea4ca53c297 32 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced May 29, 2026