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ArcDuo, Guarded Depth Paired Ophthalmic Knife 10mm ARC-0001

by MicroSurgical Technology 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 Number00844685014309 UDI-DI Date10 Oct 2025ListedStatusListed 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  • Withdrawn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
ArcDuo, Guarded Depth Paired Ophthalmic Knife 10mm
Generic Name
Ophthalmic knife, single-use
Model / Reference
ARC-0001
Primary DI / UDI-DI
00844685014309
FDA Product Code
HNN
GMDN Term
Ophthalmic knife, single-use
Device Class
Class I
Regulation Number
886.4350
GUDID distribution status
In Commercial Distribution

Other devices from MicroSurgical Technology Inc.

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Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No