Skip to content

Dermapac, Inc. 8324

by Dermapac Inc.

Dermapac, Inc. 8324 is a Class I device made by Dermapac Inc., listed in FDA GUDID since 12 Sep 2022 (UDI-DI 10810102271249), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10810102271249 UDI-DI Date12 Sep 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  • Withdrawn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
Dermapac, Inc.
Generic name
Tracheostomy kit, single-use
Model / reference
8324
Primary DI / UDI-DI
10810102271249
FDA product code
FSM
GMDN term
Tracheostomy kit, single-use
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tracheostomy kit, single-use

Similar devices in this category

Other devices filed under Tracheostomy kit, single-use.

Other devices from Dermapac Inc.

See all devices from Dermapac Inc. →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
Other properties (12, all answered No)