FDA.reportPublic FDA data

PeelVue Pro

Primary DI
10615375010294
Brand
PeelVue Pro
Company
Kerr Corporation
Model
37068
Device description
Self-Sealing Sterilization Pouches
Published
2019-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162258000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162258000Self Sealing Sterilization PouchesTianchang Jiarui Packaging Material Co., Ltd.2017-04-28FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20615375010291PackageGS110In Commercial Distribution
10615375010294PrimaryGS10
00615375010297Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061537501029120615375010291
1061537501029410615375010294
00615375010297006153750102976153750102970615375010297

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at ambient room temperature. Keep dry. Keep away from sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-597-7123KerrCustCare@kavokerr.com

Regulatory Flags#

DUNS number
199354556
Device count
200
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195062145582ZenFlex CM818-36022026-02-19
00195062145599ZenFlex CM818-36032026-02-19
00195062145605ZenFlex CM818-36042026-02-19
00195062145612ZenFlex CM818-36052026-02-19
00195062145629ZenFlex CM818-36062026-02-19
00195062145636ZenFlex CM818-36072026-02-19
00195062145643ZenFlex CM818-36082026-02-19
00195062145650ZenFlex CM818-36092026-02-19
00195062145667ZenFlex CM818-36102026-02-19
00195062145674ZenFlex CM818-36112026-02-19
00195062145681ZenFlex CM818-36122026-02-19
00195062145698ZenFlex CM818-36132026-02-19
00195062145704ZenFlex CM818-36142026-02-19
00195062145711ZenFlex CM818-36152026-02-19
00195062145728ZenFlex CM818-36162026-02-19
00195062145735ZenFlex CM818-36172026-02-19
00195062145742ZenFlex CM818-36182026-02-19
00195062145247ZenFlex CM818-36022026-02-19
00195062145254ZenFlex CM818-36032026-02-19
00195062145261ZenFlex CM818-36042026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201053JMUJMU DENTAL, INCJOJ2026-06-05
00840456201060JMUJMU DENTAL, INCJOJ2026-06-05
00840456201077JMUJMU DENTAL, INCJOJ2026-06-05
00840456201275JMUJMU DENTAL, INCJOJ2026-06-05
00840456201275JMUJMU DENTAL, INCFRG2026-06-05
00840456201282JMUJMU DENTAL, INCJOJ2026-06-05
00840456201282JMUJMU DENTAL, INCFRG2026-06-05
00840456201299JMUJMU DENTAL, INCJOJ2026-06-05
00840456201299JMUJMU DENTAL, INCFRG2026-06-05
00840456201305JMUJMU DENTAL, INCJOJ2026-06-05
00840456201305JMUJMU DENTAL, INCFRG2026-06-05
00840456201312JMUJMU DENTAL, INCJOJ2026-06-05
00840456201312JMUJMU DENTAL, INCFRG2026-06-05
00840456201831JMUJMU DENTAL, INCFRG2026-06-05
00840456201831JMUJMU DENTAL, INCJOJ2026-06-05
00840456201848JMUJMU DENTAL, INCFRG2026-06-05
00840456201848JMUJMU DENTAL, INCJOJ2026-06-05
00840456201855JMUJMU DENTAL, INCFRG2026-06-05
00840456201855JMUJMU DENTAL, INCJOJ2026-06-05
00840456201862JMUJMU DENTAL, INCFRG2026-06-05
00840456201862JMUJMU DENTAL, INCJOJ2026-06-05
00840456201879JMUJMU DENTAL, INCFRG2026-06-05
00840456201879JMUJMU DENTAL, INCJOJ2026-06-05
00840456201886JMUJMU DENTAL, INCFRG2026-06-05
00840456201886JMUJMU DENTAL, INCJOJ2026-06-05
00840456201893JMUJMU DENTAL, INCFRG2026-06-05
00840456201893JMUJMU DENTAL, INCJOJ2026-06-05
00840456201909JMUJMU DENTAL, INCFRG2026-06-05
00840456201909JMUJMU DENTAL, INCJOJ2026-06-05
00840456201916JMUJMU DENTAL, INCFRG2026-06-05