UDI device identifier

Novasight Hybrid™ Catheter TA-06-0001

UDI device identifier 00628055603054 · Conavi Medical Inc

Key facts

Primary DI 00628055603054
Brand name Novasight Hybrid™ Catheter
Version or model TA-06-0001
Company Conavi Medical Inc
DUNS number 200125243
Product code OBJ
GMDN term Coronary optical coherence tomography system catheter
Premarket submission K172258
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Sep 9, 2020
Version date Nov 9, 2022
Description Imaging catheter

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 100–999 GUDID devices with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

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