AnchorKnot Knot Pusher (2-0) and Suture Cutter (2-0)

GUDID 07540299000143

Baylis Medical Technologies Inc

Arthroscopic surgical procedure kit, non-medicated, single-use
Primary Device ID07540299000143
NIH Device Record Key23963e7e-627c-43e0-b556-38e77e9ebedb
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnchorKnot Knot Pusher (2-0) and Suture Cutter (2-0)
Version Model NumberPSZ-400-311
Company DUNS240389677
Company NameBaylis Medical Technologies Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com
Phone905-948-5800
Emailinfo@baylismedtech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100685447001751 [Previous]
GS107540299000143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-24
Device Publish Date2022-11-16

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07540299000372 - PowerWire Pro Radiofrequency Guidewire Kit2024-03-26 PowerWire Pro RF Guidewire; RFP-100A Connector Cable
07540299000389 - PowerWire Pro Radiofrequency Guidewire Kit2024-03-26 PowerWire Pro RF Guidewire; RFP-100A Connector Cable
07540299000396 - PowerWire Pro Radiofrequency Guidewire Kit2024-03-26 PowerWire Pro RF Guidewire; RFP-100A Connector Cable
07540299000402 - PowerWire Pro Radiofrequency Guidewire Kit2024-03-26 PowerWire Pro RF Guidewire; RFP-100A Connector Cable
07540299000419 - PowerWire Pro Radiofrequency Guidewire Kit2024-03-26 PowerWire Pro RF Guidewire; RFP-100A Connector Cable

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