Breezeway II® Plus Delivery Sheath BG060079180L

GUDID 00885672010386

DELIVERY SHEATH PLUS, 6F 79CM 180° LKIT

Oscor Inc.

Vascular guide-catheter, single-use
Primary Device ID00885672010386
NIH Device Record Keyd38ed570-b92b-4297-aa61-a9d3b2989155
Commercial Distribution StatusIn Commercial Distribution
Brand NameBreezeway II® Plus Delivery Sheath
Version Model NumberBG060079180L
Catalog NumberBG060079180L
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 Kittrue
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
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

Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter
Lumen/Inner Diameter2.1 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.9 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100885672010386 [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 Date2021-09-13
Device Publish Date2021-09-03

On-Brand Devices [Breezeway II® Plus Delivery Sheath]

00885672010553DELIVERY SHEATH PLUS, 14F 79CM 45° LKIT
00885672010546DELIVERY SHEATH PLUS, 12F 79CM 45° LKIT
00885672010539DELIVERY SHEATH PLUS, 11F 79CM 180° LKIT
00885672010522DELIVERY SHEATH PLUS, 11F 79CM 45° LKIT
00885672010515DELIVERY SHEATH PLUS, 10F 110CM 45° LKIT
00885672010508DELIVERY SHEATH PLUS, 10F 79CM 180° LKIT
00885672010492DELIVERY SHEATH PLUS, 10F 79CM 45° LKIT
00885672010485DELIVERY SHEATH PLUS, 9F 110CM 45° LKIT
00885672010478DELIVERY SHEATH PLUS, 9F 79CM 180° LKIT
00885672010461DELIVERY SHEATH PLUS, 9F 79CM 45° LKIT
00885672010454DELIVERY SHEATH PLUS, 8F 110CM 45° LKIT
00885672010447DELIVERY SHEATH PLUS, 8F 79CM 180° LKIT
00885672010430DELIVERY SHEATH PLUS, 8F 79CM 45° LKIT
00885672010423DELIVERY SHEATH PLUS, 7F 110CM 45° LKIT
00885672010416DELIVERY SHEATH PLUS, 7F 79CM 180° LKIT
00885672010409DELIVERY SHEATH PLUS, 7F 79CM 45° LKIT
00885672010393DELIVERY SHEATH PLUS, 6F 110CM 45° LKIT
00885672010386DELIVERY SHEATH PLUS, 6F 79CM 180° LKIT
00885672010379DELIVERY SHEATH PLUS, 6F 79CM 45° LKIT
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