Anchor Curved Tip Kerrison Rongeur

GUDID 00685447002024

Baylis Médicale Cie Inc

Orthopaedic joint/limb rongeur
Primary Device ID00685447002024
NIH Device Record Key530565a8-ce17-413a-93da-d37f8a7766bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnchor Curved Tip Kerrison Rongeur
Version Model NumberPSZ-400-201
Company DUNS249225954
Company NameBaylis Médicale Cie 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com
Phone5144889801
Emailinfo@baylismedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100685447002024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


[00685447002024]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-12
Device Publish Date2017-06-16

Devices Manufactured by Baylis Médicale Cie Inc

00685447020080 - VersaCross Connect™2024-08-28 Access Solution for CARTO VIZIGO™ Sheath
00685447020103 - VersaCross Connect™2024-08-28 Access Solution for CARTO VIZIGO™ Sheath
00685447019046 - VersaCross Connect Access Solution for FARADRIVE2024-01-19 1 x VersaCross Connect Transseptal Dilator; 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))
00685447019053 - VersaCross Connect Access Solution for FARADRIVE2024-01-19 1 x VersaCross Connect Transseptal Dilator; 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))
00685447019060 - VersaCross Connect Access Solution for FARADRIVE2024-01-19 1 x VersaCross Connect Transseptal Dilator; 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))
00685447019077 - VersaCross Connect Access Solution for FARADRIVE2024-01-19 1 x VersaCross Connect Transseptal Dilator; 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))
00685447005964 - SupraCross Steerable Sheath2023-11-16 SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
00685447005971 - SupraCross Steerable Sheath2023-11-16 SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.