Sentrex BioSponge MPD

GUDID 00850047730091

Bionova Medical Inc.

Cavity-wound management dressing, non-antimicrobial
Primary Device ID00850047730091
NIH Device Record Key9a70b8ca-a78b-4c8c-9f17-518f96af0afb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSentrex BioSponge MPD
Version Model Number501-1010
Company DUNS080325588
Company NameBionova Medical 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone901-748-2581
Emailinfo@bionovamedical.com
Phone901-748-2581
Emailinfo@bionovamedical.com
Phone901-748-2581
Emailinfo@bionovamedical.com
Phone901-748-2581
Emailinfo@bionovamedical.com
Phone901-748-2581
Emailinfo@bionovamedical.com
Phone901-748-2581
Emailinfo@bionovamedical.com
Phone901-748-2581
Emailinfo@bionovamedical.com
Phone901-748-2581
Emailinfo@bionovamedical.com
Phone901-748-2581
Emailinfo@bionovamedical.com
Phone901-748-2581
Emailinfo@bionovamedical.com
Phone901-748-2581
Emailinfo@bionovamedical.com
Phone901-748-2581
Emailinfo@bionovamedical.com
Phone901-748-2581
Emailinfo@bionovamedical.com
Phone901-748-2581
Emailinfo@bionovamedical.com
Phone901-748-2581
Emailinfo@bionovamedical.com
Phone901-748-2581
Emailinfo@bionovamedical.com

Device Dimensions

Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850047730091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-02
Device Publish Date2023-09-24

On-Brand Devices [Sentrex BioSponge MPD]

00850047730107501-1020
00850047730091501-1010
00850047730084501-0505

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