MyOstomy

GUDID 20860010399716

Ostomy Suction Device, 25mm

Myostomy Distribution LLC

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Primary Device ID20860010399716
NIH Device Record Key0223090b-76cc-45ac-b229-858ff4fd25ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyOstomy
Version Model NumberG4772500
Company DUNS120805657
Company NameMyostomy Distribution LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100860010399712 [Primary]
GS120860010399716 [Package]
Contains: 00860010399712
Package: [75 Units]
In Commercial Distribution

FDA Product Code

GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-22
Device Publish Date2023-09-14

On-Brand Devices [MyOstomy]

20860010399716Ostomy Suction Device, 25mm
20860010399709Ostomy Suction Device, 22.5mm

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