Element Self Sealing Sterilization Pouch 500-00011

GUDID D830500000112

Self Sealing Sterilization Pouch 5.25’’ x 10” (13.3 cm x 25.4 cm)

GS Medical Packaging Inc

Sterilization packaging, single-use
Primary Device IDD830500000112
NIH Device Record Keyb94e6e46-2fdf-48ac-ba90-5f3824669d1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameElement Self Sealing Sterilization Pouch
Version Model Number500-00011
Catalog Number500-00011
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone905.271.1523
Emailhamed@hedygs.com
Phone905.271.1523
Emailhamed@hedygs.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD830500000110 [Primary]
HIBCCD830500000111 [Package]
Contains: D830500000110
Package: Box [200 Units]
In Commercial Distribution
HIBCCD830500000112 [Package]
Contains: D830500000111
Package: Case [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-26
Device Publish Date2019-11-18

On-Brand Devices [Element Self Sealing Sterilization Pouch]

D830500000112Self Sealing Sterilization Pouch 5.25’’ x 10” (13.3 cm x 25.4 cm)
D830500000102Self Sealing Sterilization Pouch Size: 3.5’’ x 10” (8.9cm x 25.4cm)
D830500000091Self Sealing Sterilization Pouch 2.75’’ x 10”
D83050000081Self Sealing Sterilization Pouch 3.5"X5.5"

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