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Dynamis Robotic Surgical System TPL0001-04

by LEM Surgical AG

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 Number07649998256704 UDI-DI Date7 Jul 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  • Withdrawn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
Dynamis Robotic Surgical System
Generic Name
Robotic surgical navigation system
Model / Reference
TPL0001-04
Primary DI / UDI-DI
07649998256704
510(k) Number
FDA Product Code
OLO
GMDN Term
Robotic surgical navigation system
Device Class
Class II
Regulation Number
882.4560
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from LEM Surgical AG

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No