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MANI ENT Knife NKT35

by Mani, Inc.

MANI ENT Knife NKT35 is a Class I device made by Mani, Inc., listed in FDA GUDID since 30 Sep 2022 (UDI-DI 14546951370579), 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 Number14546951370579 UDI-DI Date30 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  • Withdrawn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
MANI ENT Knife
Generic name
Scalpel, single-use
Model / reference
NKT35
Primary DI / UDI-DI
14546951370579
FDA product code
KTG
GMDN term
Scalpel, single-use
Device class
Class I
Regulation number
874.4420
GUDID distribution status
In Commercial Distribution

Related devices

Category: Scalpel, single-use

Similar devices in this category

Other devices filed under Scalpel, single-use.

Other devices from Mani, Inc.

See all devices from Mani, Inc. →

Properties

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