Foam Medium

GUDID 00849405031222

Genadyne Green Foam Dressing is a fully reticulated hydrophobic polyurethane foam made with polyether resin to allow better hydrolytic stability. While under pressure, this design allows increased performance in moist environments. The Foam promotes perfusion and assist in tissue granulation. In addition, fraying is reduced, preventing stray pieces from being left in the wound bed. It is a non-invasive, non-implantable medical device.

GENADYNE BIOTECHNOLOGIES INC.

Negative-pressure wound therapy system foam dressing
Primary Device ID00849405031222
NIH Device Record Key8a334ecf-fcb1-414f-9bfe-373f9ac1de30
Commercial Distribution StatusIn Commercial Distribution
Brand NameFoam Medium
Version Model NumberXF-MFOAM2
Company DUNS006616130
Company NameGENADYNE BIOTECHNOLOGIES INC.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Width18 Centimeter
Width18 Centimeter
Width18 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100849405031222 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-27

Devices Manufactured by GENADYNE BIOTECHNOLOGIES INC.

00849405000051 - XLR8 Canister2024-08-13 All canisters are made out of ABS material. It is used as a disposable item to collect patient’s exudates.
00849405000396 - XLR8 Canister2024-08-13 All canisters are made out of ABS material. It is used as a disposable item to collect patient’s exudates.
00849405000402 - XLR8 Canister2024-08-13 All canisters are made out of ABS material. It is used as a disposable item to collect patient’s exudates
00849405000419 - XLR8 Canister2024-08-13 All canisters are made out of ABS material. It is used as a disposable item to collect patient’s exudates
00849405000426 - XLR8 Canister2024-08-13 All canisters are made out of ABS material. It is used as a disposable item to collect patient’s exudates.
00849405001638 - Hybrid Dressing2024-08-08 The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP-D1050(10 cm x 50 cm), UP-D1030(
00849405001645 - Hybrid Dressing2024-08-08 The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP-D1050(10 cm x 50 cm), UP-D1030(
00849405001652 - Hybrid Dressing2024-08-08 The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP-D1050(10 cm x 50 cm), UP-D1030(

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