Foam Kit Large

GUDID 00849405021131

The Genadyne Foam Kit Large consists of a XLR8 Port, two XLR8 Transparent Film and a Foam Large. Each component is packaged, sealed and sterilized individually and then bagged into a kit

GENADYNE BIOTECHNOLOGIES INC.

Negative-pressure wound therapy system foam dressing
Primary Device ID00849405021131
NIH Device Record Key18a86abe-5d08-4b87-a449-00c13046b393
Commercial Distribution StatusIn Commercial Distribution
Brand NameFoam Kit Large
Version Model NumberXF-DLGF1
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 Kittrue
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 Identifiers

Device Issuing AgencyDevice ID
GS100849405021131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OMPNegative Pressure Wound Therapy Powered Suction Pump

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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(

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.