Professional's Choice

GUDID D8304421011

Professional's Choice Self Seal Sterilization Pouch Size 3.5"X10"

GS Medical Packaging Inc

Sterilization packaging, single-use
Primary Device IDD8304421011
NIH Device Record Key595a4809-ef85-475b-8747-f36e72bbde09
Commercial Distribution StatusIn Commercial Distribution
Brand NameProfessional's Choice
Version Model Number442101
Company DUNS246113039
Company NameGS Medical Packaging 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9052711523
Emailaccounting@gsmedicalpackaging.com
Phone9052711523
Emailaccounting@gsmedicalpackaging.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD830442101 [Primary]
HIBCCD8304421011 [Package]
Contains: D830442101
Package: cardboard box [200 Units]
In Commercial Distribution
HIBCCD8304421012 [Package]
Package: cardboard box [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2016-10-06