Xclose Plus XC-201-01

GUDID 00860323000206

TISSUE REPAIR SYSTEM WITH INVISILOC TECHNOLOGY

Kr Medical Technologies LLC

Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament
Primary Device ID00860323000206
NIH Device Record Keyf0964eb6-07e6-45c7-992a-4469ff56d7af
Commercial Distribution StatusIn Commercial Distribution
Brand NameXclose Plus
Version Model NumberXC-201-01
Catalog NumberXC-201-01
Company DUNS030742286
Company NameKr Medical Technologies LLC
Device Count1
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com
Phone877-326-8539
Emailcustomerservice@krmedtech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860323000206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GATSuture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2015-10-24

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