PeelVue Pro

GUDID 10615375010300

Self-Sealing Sterilization Pouches

Kerr Corporation

Sterilization packaging, single-use
Primary Device ID10615375010300
NIH Device Record Key52237dde-4bb9-4ecf-bc8c-15facc50c2ae
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeelVue Pro
Version Model Number37067
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

Device Dimensions

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.

Device Identifiers

Device Issuing AgencyDevice ID
GS100615375010303 [Unit of Use]
GS110615375010300 [Primary]
GS120615375010307 [Package]
Package: CASE [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOJIndicator, Physical/Chemical Sterilization Process

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 Date2019-07-01

On-Brand Devices [PeelVue Pro ]

10615375010331Self-Sealing Sterilization Pouches
10615375010324Self-Sealing Sterilization Pouches
10615375010317Self-Sealing Sterilization Pouches
10615375010300Self-Sealing Sterilization Pouches
10615375010294Self-Sealing Sterilization Pouches
10615375010287Self-Sealing Sterilization Pouches
10615375010270Self-Sealing Sterilization Pouches
10615375010263Self-Sealing Sterilization Pouches
10615375010256Self-Sealing Sterilization Pouches
10615375010249Self-Sealing Sterilization Pouches
10615375010232Self-Sealing Sterilization Pouches
10615375010225Self-Sealing Sterilization Pouches
00615375011812Self-Sealing Sterilization Pouches (Case has a different SKU number, i.e. 37151)

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