Baylis Med Tech Passport Steerable Sheath PSS0855517

GUDID 00885672012601

Passport Steerable Sheath 8.5F

Oscor Inc.

Vascular guide-catheter, single-use
Primary Device ID00885672012601
NIH Device Record Keyb95f1f59-4c37-4ad7-b849-4058beb6ce8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBaylis Med Tech Passport Steerable Sheath
Version Model NumberPSS0855517
Catalog NumberPSS0855517
Company DUNS101835833
Company NameOscor 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter2.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter2.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter2.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter2.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter2.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter2.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter2.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter2.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter2.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter2.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter2.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter2.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter2.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter2.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter2.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter2.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter2.8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.2 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100885672012601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBIntroducer, catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-23
Device Publish Date2023-03-15

On-Brand Devices [Baylis Med Tech Passport Steerable Sheath]

00885672012625Passport Steerable Sheath 13.8F
00885672012618Passport Steerable Sheath 12F
00885672012601Passport Steerable Sheath 8.5F
00885672012595Passport Steerable Sheath 7F TD Curve
00885672012588Passport Steerable Sheath 7F
00885672012571Passport Steerable Sheath 7F
00885672012564Passport Steerable Sheath 7F
00885672012557Passport Steerable Sheath 7F
00885672012540Passport Steerable Sheath 7F
00885672012533Passport Steerable Sheath 6.5F Dual Dilator
00885672012526Passport Steerable Sheath 6.5F
00885672012519Passport Steerable Sheath 6.5F
00885672012502Passport Steerable Sheath 6.5F
00885672012496Passport Steerable Sheath 6.5F
00885672012489Passport Steerable Sheath 6.5F

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