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Absorbable Dusting Powder

by Hubinger Co.

PMA N85356

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA N85356

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberN85356 Date20 Dec 1978ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic Name
Powder, dusting, surgical
PMA Number
FDA Product Code
KGP
Advisory Committee
General Hospital
FDA Decision
APPR Approved
PMA Supplement
S001

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This is an absorbable surgical dusting powder, classified under the nomenclature as a generic powder, dusting, surgical. It is designed to reduce friction and facilitate surgical procedures by providing a dry, non-adherent surface.

The powder is supplied as a sterile, single-use product and is intended for use in general hospital settings. It is regulated under an FDA Premarket Approval (PMA) with PMA Number N85356 and is distributed by Hubinger Co. based in Keokuk, IA. No specific MRI safety or reusable status is indicated in the data.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Absorbable Dusting Powder in surgical procedures?

    The Absorbable Dusting Powder is designed to reduce friction during surgery by creating a dry, non-adherent surface. This helps facilitate smoother movements of surgical instruments and tissues, improving overall procedural efficiency.

  • Is the Absorbable Dusting Powder reusable, or is it meant for single-use only?

    The Absorbable Dusting Powder is explicitly labeled as a sterile, single-use product. This means it should not be reused after application in a surgical setting to maintain sterility and safety standards.

  • How is the Absorbable Dusting Powder supplied, and where is it distributed from?

    The powder is supplied as a sterile, single-use product and is distributed by Hubinger Co., located at 601 Main St., Keokuk, IA 52632. It is intended for use in general hospital settings.

  • What regulatory pathway does the Absorbable Dusting Powder follow, and what is its approval status?

    The Absorbable Dusting Powder is regulated under an FDA Premarket Approval (PMA) process, with approval granted on December 20, 1978. The PMA number assigned is N85356, confirming its regulatory clearance for use in the United States.

  • Can this powder be used in MRI-compatible procedures, or is there any indication about its MRI safety?

    The provided data does not specify whether the Absorbable Dusting Powder is MRI-safe or compatible. If MRI safety is a concern for your procedure, additional verification or documentation from Hubinger Co. would be necessary.