ERPeak

GUDID 60888937027190

IVD Sample kit

Coopersurgical, Inc.

General specimen container IVD, additive/medium
Primary Device ID60888937027190
NIH Device Record Keya087770f-ff6b-41cd-bcc5-66ed024117d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameERPeak
Version Model NumberER20190829-04
Company DUNS801895244
Company NameCoopersurgical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS160888937027190 [Primary]

FDA Product Code

NNKContainer, Specimen Mailer And Storage, Non-Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-18
Device Publish Date2024-04-10

On-Brand Devices [ERPeak]

60888937027206IVD Sample kit
60888937027190IVD Sample kit
60888937027183IVD Sample kit
60888937027176IVD Sample kit

Trademark Results [ERPeak]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ERPEAK
ERPEAK
88109017 5864194 Live/Registered
CooperSurgical, Inc.
2018-09-07

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