Electro-Mesh Panel

GUDID B872EMSP440

Electro-Mesh Panel 4x4

PRIZM MEDICAL, INC.

Transcutaneous electrical stimulation electrode, single-use
Primary Device IDB872EMSP440
NIH Device Record Key992152f0-a2f3-4221-8bcc-f00a729b9227
Commercial Distribution StatusIn Commercial Distribution
Brand NameElectro-Mesh Panel
Version Model NumberEMSP44
Company DUNS790271118
Company NamePRIZM 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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB872EMSP440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-14
Device Publish Date2024-06-06

On-Brand Devices [Electro-Mesh Panel]

B872EMSP480Electro-Mesh Panel 4x8
B872EMSP440Electro-Mesh Panel 4x4
B872EMSP240Electro-Mesh Panel 1.5x4

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