RS Blue

GUDID 19551012412810

ECO MEDI GLOVE SDN. BHD.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID19551012412810
NIH Device Record Key1daba655-32d5-448d-9d52-1d9c53226c94
Commercial Distribution StatusIn Commercial Distribution
Brand NameRS Blue
Version Model Number2RSNE8300
Company DUNS813056487
Company NameECO MEDI GLOVE SDN. BHD.
Device Count100
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 Datetrue
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
GS109551012412813 [Primary]
GS119551012412810 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZAPolymer Patient Examination Glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-03
Device Publish Date2023-06-23

On-Brand Devices [RS Blue]

195510124128652RSNE8305
195510124128582RSNE8304
195510124128412RSNE8303
195510124128342RSNE8302
195510124128272RSNE8301
195510124128102RSNE8300

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