Micro Plug Set

Primary DI
00867966000105
Brand
Micro Plug Set
Company
KA MEDICAL LLC
Model
90000
Catalog number
90000
Device description
Micro Plug Set - 3mm
Published
2019-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRDDevice, Vascular, For Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182944000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182944000Dr. Amplatz Micro PlugKa Medical, LLC2019-04-17KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00867966000105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00867966000105008679660001058679660001050867966000105

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization plug, metallicA sterile, non-bioabsorbable, metal device intended to be implanted in a non-neurovascular blood vessel, permanently or long-term, to occlude blood flow typically for treatment of an aneurysm, tumour (e.g., nephroma, hepatoma, uterine fibroids), and/or arteriovenous malformation (AVM). It is in the form of an expandable metal scaffold, which once expanded is intended to induce thrombosis and create a blockage; it is typically supplied with instruments dedicated to implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry area.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
651-262-2810info@ka-medical.com

Regulatory Flags#

DUNS number
079456139
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00867966000112Micro Plug Set90001900012019-04-25
00867966000129Micro Plug Set90002900022019-04-25
00867966000136Micro Plug Set 90003900032019-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10886704077022DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077039DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077046DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077077DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077176DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077183DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077299DELTAXSFTCerenovus, Inc.KRD2016-11-16
10886704077374DELTAXSFTCerenovus, Inc.KRD2016-11-16
10886704076933DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076940DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077091DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077114DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077121DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077138DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077145DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077152DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077169DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077190DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077213MICRUSFRAMECerenovus, Inc.KRD2016-11-16
10886704077220DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077237DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077381GALAXY G3Cerenovus, Inc.KRD2016-11-16
10886704077398GALAXY G3Cerenovus, Inc.KRD2016-11-16
10886704077404GALAXY G3Cerenovus, Inc.KRD2016-11-16
10886704077411GALAXY G3Cerenovus, Inc.KRD2016-11-16
10886704077428GALAXY G3Cerenovus, Inc.KRD2016-11-16
10886704077435GALAXY G3Cerenovus, Inc.KRD2016-11-16