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001-007S-P

by PENTAX of America Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 10 Nov 2026. What this means

Regulatory status

as of registry sync 10 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04961333245185 UDI-DI Date3 Apr 2018ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Medical capital equipment storage bag/case
Model / reference
001-007S-P
Primary DI / UDI-DI
04961333245185
FDA product code
KQM
GMDN term
Medical capital equipment storage bag/case
Device class
Class I
Regulation number
878.4160
GUDID distribution status
In Commercial Distribution

Overview

AI-generated summary, 10 Nov 2026

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

001-007S-P is a medical capital equipment storage bag/case. FDA lists it under the product name a surgical camera and accessories.

The device is classified as Class I. Its product code is KQM and it falls under regulation 878.4160. It is currently in commercial distribution.

Related devices

Category: Medical capital equipment storage bag/case

Other devices from PENTAX of America Inc.

See all devices from PENTAX of America Inc. →

Questions

AI-generated answers, 10 Nov 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 001-007S-P?

    The record describes it as "DEMO CASE FOR POLE STAND". FDA lists it under the product name "Camera, Surgical And Accessories". Its GMDN device type is "Medical capital equipment storage bag/case". It is recorded as Class I.

  • What are the product code and regulation of the 001-007S-P?

    FDA records the 001-007S-P under product code KQM and regulation number 878.4160.

  • Who makes the 001-007S-P?

    PENTAX of America Inc. is the manufacturer on record for the 001-007S-P.

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No