UDI device identifier

Duploject Easy Prep 1501250

UDI device identifier 00085412095837 · BAXTER INTERNATIONAL INC.

Key facts

Primary DI 00085412095837
Brand name Duploject Easy Prep
Version or model 1501250
Catalog number 1501250
Company BAXTER INTERNATIONAL INC.
DUNS number 005146311
Product code FMF
GMDN term Open-surgery adhesive/sealant applicator, dual-channel
Premarket submission K020666
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Sep 24, 2016
Version date Jul 6, 2018
Description Fibrin Sealant Preparation and Application System for the preparation and application of Tisseel Two-component Fibrin Sealant (2 mL Kit)

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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