FDA.reportPublic FDA data

HedySeal PRO Self-Sealing Sterilization Pouches

Primary DI
D903610HSP402
Brand
HedySeal PRO Self-Sealing Sterilization Pouches
Company
Hedy Canada
Model
610HSP-40
Catalog number
610HSP-40
Device description
HedySeal Pro Pouches 3.5"x9" with Class 4 Indicators
Published
2019-01-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D903610HSP401PackageHIBCC200In Commercial Distribution
D903610HSP402PackageHIBCC6In Commercial Distribution
D903610HSP40PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
905.271.1523HAMED@HEDYGS.COM

Regulatory Flags#

DUNS number
249482399
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D903410MB2Hedy SoftMask410MB410MB2018-11-23
D903410MG2Hedy SoftMask410MG410MG2018-11-23
D903410MP2Hedy SoftMask410MP410MP2018-11-23
D903410MW2Hedy SofMask410MW410MW2018-11-23
D903420HFB2Hedy SoftMask420HFB420HFB2018-11-23
D903420HFG2Hedy SoftMask420HFG420HFG2018-11-23
D903420HFP2Hedy SoftMask420HFP420HFP2018-11-23
D903420HFW2Hedy SoftMask420HFW420HFW2018-11-23
D903420LFB2Hedy SoftMask420LFB420LFB2018-11-23
D903420LFG2Hedy SoftMask420LFG420LFG2018-11-23
D903420LFP2Hedy SoftMask420LFP420LFP2018-11-23
D903420LFW2Hedy SoftMask420LFW420LFW2018-11-23
D903430HVB2Hedy SoftMask430HVB430HVB2018-11-23
D903610HSP102HedySeal PRO Self-Sealing Sterilization Pouches 610HSP-10610HSP-102019-01-17
D903610HSP202HedySeal PRO Self-Sealing Sterilization Pouches610HSP-20610HSP-202019-01-17
D903610HSP302HedySeal PRO Self-Sealing Sterilization Pouches610HSP-30610HSP-302019-01-17
D903610HSP502HedySeal PRO Self-Sealing Sterilization Pouches610HSP-50610HSP-502019-01-17
D903610HSP602HedySeal PRO Self-Sealing Sterilization Pouches610HSP-60610HSP-602019-01-17
D903HEBEHO11Elements by Hedy Barrier EnvelopesHE-BEHO1HE-BEHO12019-03-18
D903HEBEHO21Elements by Hedy Barrier EnvelopesHE-BEHO2HE-BEHO22019-03-18

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