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KLS E-Coupling Adapter PDEC-1000-3

by Pro-Dex, Inc.

KLS E-Coupling Adapter PDEC-1000-3 is a Class I device made by Pro-Dex, Inc., listed in FDA GUDID since 29 Mar 2022 (UDI-DI 00856482008016), 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 Number00856482008016 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  • Withdrawn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 E-Coupling Adapter
Generic name
Surgical power tool adaptor
Model / reference
PDEC-1000-3
Primary DI / UDI-DI
00856482008016
FDA product code
GEY, GXL, HWE
GMDN term
Surgical power tool adaptor
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: Surgical power tool adaptor

Similar devices in this category

Other devices filed under Surgical power tool adaptor.

Other devices from Pro-Dex, Inc.

See all devices from Pro-Dex, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)