UDI device identifier

Recapit 1

UDI device identifier 00010705400708 · MAJESTIC DRUG CO. INC.

Key facts

Primary DI 00010705400708
Brand name Recapit
Version or model 1
Company MAJESTIC DRUG CO. INC.
DUNS number 001496777
Product code EMA
GMDN term Home-use dental cement
Premarket submission K964773
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Jul 27, 2016
Version date Jul 6, 2018
Description Recapit is a Eugenol free temporary dental cement for re-cementing loose caps or crowns

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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