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KLS MaxDriver 2 KLS-SD-2000

by Pro-Dex, Inc.

KLS MaxDriver 2 KLS-SD-2000 is a Class I device made by Pro-Dex, Inc., listed in FDA GUDID since 29 Mar 2022 (UDI-DI 00856482008115), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00856482008115 UDI-DI Date29 Mar 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
KLS MaxDriver 2
Generic name
Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Model / reference
KLS-SD-2000
Primary DI / UDI-DI
00856482008115
FDA product code
HWE, GEY, GXL
GMDN term
Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Device class
Class I
Regulation number
878.4820, 882.4900
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

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

Similar devices in this category

Other devices filed under Bone/joint surgical power tool motorized handpiece/set, electric, reusable.

Other devices from Pro-Dex, Inc.

See all devices from Pro-Dex, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (9, all answered No)