Dr. Amplatz Micro Plug 90001

GUDID 00867966000112

Dr. Amplatz Micro Plug - 4mm

KA MEDICAL LLC

Non-neurovascular embolization plug, metallic
Primary Device ID00867966000112
NIH Device Record Keyca99d591-622a-4904-b4b7-71af4587c56d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDr. Amplatz Micro Plug
Version Model Number90001
Catalog Number90001
Company DUNS079456139
Company NameKA MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com
Phone651-262-2810
Emailinfo@ka-medical.com

Device Dimensions

Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry area.

Device Identifiers

Device Issuing AgencyDevice ID
GS100867966000112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRDDevice, Vascular, For Promoting Embolization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-03
Device Publish Date2019-04-25

On-Brand Devices [Dr. Amplatz Micro Plug]

00867966000136Dr. Amplatz Micro Plug - 6mm
00867966000129Dr. Amplatz Micro Plug - 5mm
00867966000112Dr. Amplatz Micro Plug - 4mm
00867966000105Dr. Amplatz Micro Plug - 3mm
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.