MicroDoc NPWT System

GUDID 00851978007504

MicroDoc NPWT System, Each, with 6" x 6" Dressings

Pensar Medical, LLC

Negative-pressure wound therapy system, electric, single-use
Primary Device ID00851978007504
NIH Device Record Key211dd2e3-378b-412f-9110-0e5d1d9df10b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicroDoc NPWT System
Version Model Number8463550 4001
Company DUNS079262228
Company NamePensar Medical, LLC
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 Numbertrue
Manufacturing Datetrue
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
GS100851978007504 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-25
Device Publish Date2024-06-17

On-Brand Devices [MicroDoc NPWT System]

00851978007511MicroDoc NPWT System, each, with Dressing Strips
00851978007504MicroDoc NPWT System, Each, with 6" x 6" Dressings
00851978007535MicroDoc NPWT System, each, with 20cm x 25cm Dressings
00851978007528MicroDoc NPWT System, each, with 10cm x 30cm Dressings
00851978007542MicroDoc ComforTech NPWT Dressing, 15cm x 20cm
00851978007573MicroDoc NPWT Dressing, 20cm x 25cm (15cm x 20cm)
00851978007566MicroDoc NPWT Dressing, 10cm x 30cm (5cm x 25cm)
00851978007559MicroDoc NPWT Dressing, 10cm x 20cm (5cm x 15cm)
00851978007597MicroDoc NPWT Breast Dressing, 20cm x 25cm (15cm x 20cm)
00851978007580MicroDoc NPWT System, each, with 20cm x 25cm (15cm x 20cm) Breast Dressings

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