Hybrid Dressing

GUDID 00849405001638

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(10 cm x 30 cm) , UP-D1520(15 cm x 20 cm) , UP-D1530(15 cm x 30 cm), XLR8 Port Pad (XP-1012, XP-1013) and 1 piece transparent film 26 cm x 30 cm cut into 5 pieces is a single patient use, disposable, non-invasive kit designed to be used along with recommended Genadyne NPWT pumps. The kit is intended to be used on moderate to low severity wounds.

GENADYNE BIOTECHNOLOGIES INC.

Negative-pressure wound therapy system foam dressing, non-antimicrobial
Primary Device ID00849405001638
NIH Device Record Keyd016e992-7a49-4e89-b497-f2f53adecba9
Commercial Distribution StatusIn Commercial Distribution
Brand NameHybrid Dressing
Version Model NumberUP-D1030
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
GS100849405001638 [Primary]

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 Date2024-08-08
Device Publish Date2024-07-31

On-Brand Devices [Hybrid Dressing]

10849405002182Hybrid Dressing 10x40 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a ho
00849405002185The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP
00849405001706Hybrid Dressing 10x30 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a ho
00849405001690Hybrid Dressing 10x50 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a ho
00849405001683Hybrid Dressing 15x20 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a ho
00849405001676Hybrid Dressing 15x30 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a ho
00849405001669The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP
00849405001652The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP
00849405001645The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP
00849405001638The Genadyne Hybrid Dressing kits which has 5 sizes Hybrid Dressing UP-D1040(10 cm x 40 cm), UP

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