HedySeal Max Self-Sealing Sterilization Pouch 610HSM-40

GUDID D903610HSM40

HedySeal Max Pouches 3.5"x9" with Class 4 indicator detachable strips

Hedy Canada

Sterilization packaging, single-use
Primary Device IDD903610HSM40
NIH Device Record Key06f401cb-c901-4dc4-a3d4-b55c7f504419
Commercial Distribution StatusIn Commercial Distribution
Brand NameHedySeal Max Self-Sealing Sterilization Pouch
Version Model Number610HSM-40
Catalog Number610HSM-40
Company DUNS249482399
Company NameHedy Canada
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone905-271-1523
EmailHAMED@HEDYGS.COM
Phone905-271-1523
EmailHAMED@HEDYGS.COM
Phone905-271-1523
EmailHAMED@HEDYGS.COM
Phone905-271-1523
EmailHAMED@HEDYGS.COM
Phone905-271-1523
EmailHAMED@HEDYGS.COM
Phone905-271-1523
EmailHAMED@HEDYGS.COM
Phone905-271-1523
EmailHAMED@HEDYGS.COM
Phone905-271-1523
EmailHAMED@HEDYGS.COM
Phone905-271-1523
EmailHAMED@HEDYGS.COM
Phone905-271-1523
EmailHAMED@HEDYGS.COM
Phone905-271-1523
EmailHAMED@HEDYGS.COM
Phone905-271-1523
EmailHAMED@HEDYGS.COM
Phone905-271-1523
EmailHAMED@HEDYGS.COM
Phone905-271-1523
EmailHAMED@HEDYGS.COM
Phone905-271-1523
EmailHAMED@HEDYGS.COM

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD903610HSM40 [Primary]
HIBCCD903610HSM401 [Package]
Package: Box [200 Units]
In Commercial Distribution
HIBCCD903610HSM402 [Package]
Contains: D903610HSM401
Package: Case [6 Units]
In Commercial Distribution

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 Number2
Public Version Date2019-11-08
Device Publish Date2019-01-17

Devices Manufactured by Hedy Canada

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D903420HFB2 - Hedy SoftMask2020-05-06 Procedure Mask
D903420HFG2 - Hedy SoftMask2020-05-06 Procedure Mask
D903420HFP2 - Hedy SoftMask2020-05-06 Procedure Mask
D903420HFW2 - Hedy SoftMask2020-05-06 Procedure Mask

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