Skip to content

Mk-800800

by Microspecialities, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10810003223378 UDI-DI Date31 Oct 2019ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic name
Keratome blade, single-use
Model / Ref / Catalog
MK-800800
Description
MicroKeratome Blades, NIDEK. Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns. 10/bx
Primary DI / UDI-DI
10810003223378
FDA product code
HNO
GMDN term
Keratome blade, single-use
Device class
Class I
Regulation number
886.4370
GUDID distribution status
In Commercial Distribution

Related devices

Category: Keratome blade, single-use

Other devices from Microspecialities, Inc.

  • MK8511CB

    Class I

  • MK8510LSK

    Class I

  • 300160

    Class I

  • 300135

    Class I

  • 30020

    Class I

  • MK8507

    Class I

See all devices from Microspecialities, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (9)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No