UDI device identifier

Transcend 101-08224500-S

UDI device identifier 00190376206578 · ALPHATEC SPINE, INC.

Key facts

Primary DI 00190376206578
Brand name Transcend
Version or model 101-08224500-S
Company ALPHATEC SPINE, INC.
DUNS number 602465783
Product code MAX
GMDN term Polymeric spinal interbody fusion cage
Premarket submission K191311
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable Yes
Publish date Jan 10, 2020
Version date Dec 7, 2022
Description TRANSCEND LIF PEEK SPACER, 8 x 22 x 45 mm, 0°

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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