RENASYS F MEDIUM W/SOFT PORT 66020795

GUDID 30040565127171

RENASYS-F Foam Dressing Kit with Soft Port Medium

SMITH & NEPHEW MEDICAL LIMITED

Wound dressing kit, medicated, sterile
Primary Device ID30040565127171
NIH Device Record Key5fcb5129-2a92-4952-8982-ea98df8b64cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameRENASYS F MEDIUM W/SOFT PORT
Version Model Number66020795
Catalog Number66020795
Company DUNS216344051
Company NameSMITH & NEPHEW MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100040565127170 [Primary]
GS130040565127171 [Package]
Contains: 00040565127170
Package: Case [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OMPNegative Pressure Wound Therapy Powered Suction Pump

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-04
Device Publish Date2020-04-24

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