Peel Vue Pro

GUDID 00615375011782

Self-Sealing Sterilization Pouches (Case has a different SKU number, i.e. 37150)

Kerr Corporation

Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use
Primary Device ID00615375011782
NIH Device Record Key41f2b799-6e14-4bf5-aa7d-e111e7984598
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeel Vue Pro
Version Model Number37148
Company DUNS199354556
Company NameKerr Corporation
Device Count200
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-597-7123
EmailKerrCustCare@kavokerr.com
Phone1-800-597-7123
EmailKerrCustCare@kavokerr.com
Phone1-800-597-7123
EmailKerrCustCare@kavokerr.com
Phone1-800-597-7123
EmailKerrCustCare@kavokerr.com
Phone1-800-597-7123
EmailKerrCustCare@kavokerr.com
Phone1-800-597-7123
EmailKerrCustCare@kavokerr.com
Phone1-800-597-7123
EmailKerrCustCare@kavokerr.com
Phone1-800-597-7123
EmailKerrCustCare@kavokerr.com
Phone1-800-597-7123
EmailKerrCustCare@kavokerr.com
Phone1-800-597-7123
EmailKerrCustCare@kavokerr.com
Phone1-800-597-7123
EmailKerrCustCare@kavokerr.com
Phone1-800-597-7123
EmailKerrCustCare@kavokerr.com
Phone1-800-597-7123
EmailKerrCustCare@kavokerr.com
Phone1-800-597-7123
EmailKerrCustCare@kavokerr.com
Phone1-800-597-7123
EmailKerrCustCare@kavokerr.com

Device Dimensions

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Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at Ambient Room Temperature, Keep Dry, Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Ambient Room Temperature, Keep Dry, Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Ambient Room Temperature, Keep Dry, Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Ambient Room Temperature, Keep Dry, Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Ambient Room Temperature, Keep Dry, Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Ambient Room Temperature, Keep Dry, Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Ambient Room Temperature, Keep Dry, Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Ambient Room Temperature, Keep Dry, Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Ambient Room Temperature, Keep Dry, Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Ambient Room Temperature, Keep Dry, Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Ambient Room Temperature, Keep Dry, Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Ambient Room Temperature, Keep Dry, Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Ambient Room Temperature, Keep Dry, Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Ambient Room Temperature, Keep Dry, Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Ambient Room Temperature, Keep Dry, Keep Away from Sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100615375011782 [Unit of Use]
GS110615375011789 [Primary]
GS120615375011786 [Package]
Contains: 10615375011789
Package: CASE [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRGWrap, Sterilization

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-07
Device Publish Date2020-12-30

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