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SureCUT 5001

by Sentreheart, Inc

SureCUT 5001 is a Class I device made by Sentreheart, Inc, listed in FDA GUDID since 17 Sep 2018 (UDI-DI M95550010), 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 NumberM95550010 UDI-DI Date17 Sep 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  • Withdrawn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

Trade name
SureCUT
Generic name
Suture cutter, single-use
Model / Ref / Catalog
5001
Primary DI / UDI-DI
M95550010
FDA product code
FZT
GMDN term
Suture cutter, single-use
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FZT (Cutter, Surgical).

Other devices from Sentreheart, Inc

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    Class I
  • FindrWIRZ 4005

    Class II
  • Tensure 7 lb

    Class I
  • SofTIP Long

    Class II

See all devices from Sentreheart, Inc →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)