UDI device identifier

DUPLOCATH 1506167

UDI device identifier 00085412600048 · BAXTER INTERNATIONAL INC.

Key facts

Primary DI 00085412600048
Brand name DUPLOCATH
Version or model 1506167
Catalog number 1506167
Company BAXTER INTERNATIONAL INC.
DUNS number 005146311
Product code FMF
GMDN term Open-surgery adhesive/sealant applicator, dual-channel
Premarket submission BK170033
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Sep 28, 2018
Version date Nov 3, 2022
Description Catheter for the simultaneous application of Baxter two-component fibrin sealant in endoscopic surgery. The application of Baxter two-component fibrin sealant can be carried out via a double syringe system and the two-lumen Duplocath application catheter.

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 1,000+ 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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