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One-Step™ 00884450536780

by Merit Medical Systems, Inc.

One-Step™ 00884450536780 (OSC-8F-12PLT/C) is a Class I device made by Merit Medical Systems, Inc., listed in FDA GUDID since 27 Oct 2021 (UDI-DI 00884450536780), 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 Number00884450536780 UDI-DI Date27 Oct 2021ListedStatusListed 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  • Withdrawn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
One-Step™
Generic name
Closed-wound drain, non-bioabsorbable
Model / Ref / Catalog
00884450536780, OSC-8F-12PLT/C
Primary DI / UDI-DI
00884450536780
FDA product code
GBX
GMDN term
Closed-wound drain, non-bioabsorbable
Device class
Class I
Regulation number
878.4200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Closed-wound drain, non-bioabsorbable

Similar devices in this category

Other devices filed under Closed-wound drain, non-bioabsorbable.

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)