AnchorEntry Retractor, Expander Blades, 50 mm

GUDID 00685447001850

Baylis Médicale Cie Inc

Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable
Primary Device ID00685447001850
NIH Device Record Key3487a2d4-ac35-48b9-b854-988c5705965d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnchorEntry Retractor, Expander Blades, 50 mm
Version Model NumberPSZ-200-208
Company DUNS249225954
Company NameBaylis Médicale Cie Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS100685447001850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

[00685447001850]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-11
Device Publish Date2017-06-16

Devices Manufactured by Baylis Médicale Cie Inc

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
00685447005988 - SupraCross Steerable Sheath2023-11-16 SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
00685447006213 - SureFlex Steerable Guiding Sheath2023-11-16 SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.