UDI device identifier

Renasys 66020961

UDI device identifier 00040565127231 · SMITH & NEPHEW MEDICAL LIMITED

Key facts

Primary DI 00040565127231
Brand name Renasys
Version or model 66020961
Catalog number 66020961
Company SMITH & NEPHEW MEDICAL LIMITED
DUNS number 216344051
Product code OMP
GMDN term Wound dressing kit, medicated
Premarket submission K142979
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Sep 20, 2019
Version date Sep 7, 2023
Description The RENASYS Procedure Packs are intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via the removal of fluids, including…

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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