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Primado2 PD-2SD

by Nakanishi Inc.

Primado2 PD-2SD is a Class II device made by Nakanishi Inc., cleared under FDA 510(k) K132264 on 17 Dec 2013 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04560264560826), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K132264

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04560264560826 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK132264 Date17 Dec 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132264 decided 17 Dec 2013 Active
  • FDA GUDID UDI-DI 04560264560826 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132264
  2. Listed FDA GUDID 04560264560826

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Primado2
Generic name
Drilling power tool attachment, basic
Model / reference
PD-2SD
Primary DI / UDI-DI
04560264560826
FDA product code
HBC
GMDN term
Drilling power tool attachment, basic
Device class
Class II
Regulation number
882.4360
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)