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Insertion Tool NTER01

by Coloplast Corp.

Insertion Tool NTER01 is a Class I device made by Coloplast Corp., listed in FDA GUDID since 27 Sep 2024 (UDI-DI 05708932767521), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05708932767521 UDI-DI Date27 Sep 2024ListedStatusListed 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  • Withdrawn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
Insertion Tool
Generic name
Guidewire holder
Model / Ref / Catalog
NTER01
Primary DI / UDI-DI
05708932767521
FDA product code
KGZ
GMDN term
Guidewire holder
Device class
Class I
Regulation number
878.4200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Guidewire holder

Similar devices

Other devices filed under FDA product code KGZ (ACCESSORIES, CATHETER).

Other devices from Coloplast Corp.

See all devices from Coloplast Corp. →

Properties

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