AnchorKnot Suture Passer (2-0)

GUDID 07540299000136

Baylis Medical Technologies Inc

Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use
Primary Device ID07540299000136
NIH Device Record Key5bca6e32-f863-4e5b-bfcb-d2c68fd3fd41
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnchorKnot Suture Passer (2-0)
Version Model NumberPSZ-400-305
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 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

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
GS100685447001744 [Previous]
GS107540299000136 [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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07540299000174 - Nykanen Radiofrequency Wire kit2023-07-04 Nykanen Radiofrequency Wire; RFP-100A Connector Cable (single use)
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