Bari Ring

GUDID B033K9536N0

Kapp Surgical Instrument Co.

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable
Primary Device IDB033K9536N0
NIH Device Record Key3010ade5-8c7a-4ae0-97ac-24e18eeeebb6
Commercial Distribution StatusIn Commercial Distribution
Brand NameBari Ring
Version Model NumberNitinol Version
Company DUNS004171112
Company NameKapp Surgical Instrument Co.
Device Count3
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com
Phone216-587-4400
Emailinfo@kappsurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB033K9536N0 [Primary]
HIBCCB033K9536N1 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEUMarker, Radiographic, Implantable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

[B033K9536N0]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-10

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B033KS400440 - Coned Heparin Needles2023-06-22 Coned Heparin Needles – Size 04 - 4in
B033KS400470 - Coned Heparin Needles2023-06-22 Coned Heparin Needles – Size 04 - 7in
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