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Artisential Monopolar Spatula AMT01L-LH

by Livsmed

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number08800042706159 UDI-DI Date5 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Artisential Monopolar Spatula
Generic Name
Endoscopic electrosurgical electrode, monopolar, single-use
Model / Reference
AMT01L-LH
Primary DI / UDI-DI
08800042706159
510(k) Number
FDA Product Code
GEI
GMDN Term
Endoscopic electrosurgical electrode, monopolar, single-use
Device Class
Class II
Regulation Number
878.4400
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Outer Diameter — 8 Millimeter
Shaft Length — 450 Millimeter

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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