Foam 10x12.5cm Pack 1 66801021

GUDID 00040565125909

A reticulated, open-cell, polyurethane foam dressing designed for Negative Pressure Wound Therapy (NPWT).

SMITH & NEPHEW MEDICAL LIMITED

Wound dressing kit, medicated, sterile
Primary Device ID00040565125909
NIH Device Record Keye4725718-1a3c-47f8-814d-5a9df00eaa06
Commercial Distribution StatusIn Commercial Distribution
Brand NameFoam 10x12.5cm Pack 1
Version Model Number66801021
Catalog Number66801021
Company DUNS216344051
Company NameSMITH & NEPHEW MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
GS100040565125909 [Primary]
GS130040565125900 [Package]
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 Usetrue
Device Is Steriletrue

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-23
Device Publish Date2019-10-15

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