Broadway 8 BRW084132-01

GUDID 07613327624106

Catheter

Stryker Corporation

Vascular guide-catheter, single-use
Primary Device ID07613327624106
NIH Device Record Keyebefcc66-601f-4bda-a7a7-c54297e15bd3
Commercial Distribution StatusIn Commercial Distribution
Brand NameBroadway 8
Version Model NumberBRW084132-01
Catalog NumberBRW084132-01
Company DUNS042405446
Company NameStryker Corporation
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

Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com
Phone+1(855)916-3876
EmailNVCustomerService@stryker.com

Device Dimensions

Length132 Centimeter
Lumen/Inner Diameter0.084 Inch
Length132 Centimeter
Lumen/Inner Diameter0.084 Inch
Length132 Centimeter
Lumen/Inner Diameter0.084 Inch
Length132 Centimeter
Lumen/Inner Diameter0.084 Inch
Length132 Centimeter
Lumen/Inner Diameter0.084 Inch
Length132 Centimeter
Lumen/Inner Diameter0.084 Inch
Length132 Centimeter
Lumen/Inner Diameter0.084 Inch
Length132 Centimeter
Lumen/Inner Diameter0.084 Inch
Length132 Centimeter
Lumen/Inner Diameter0.084 Inch
Length132 Centimeter
Lumen/Inner Diameter0.084 Inch
Length132 Centimeter
Lumen/Inner Diameter0.084 Inch
Length132 Centimeter
Lumen/Inner Diameter0.084 Inch
Length132 Centimeter
Lumen/Inner Diameter0.084 Inch
Length132 Centimeter
Lumen/Inner Diameter0.084 Inch
Length132 Centimeter
Lumen/Inner Diameter0.084 Inch
Length132 Centimeter
Lumen/Inner Diameter0.084 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place.

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327624106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QJPCatheter, Percutaneous, Neurovasculature

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-03
Device Publish Date2025-01-24

Devices Manufactured by Stryker Corporation

07613327624069 - Echo2025-02-03 Intracranial Base Catheter
07613327624083 - Echo2025-02-03 Intracranial Base Catheter
07613327624106 - Broadway 82025-02-03Catheter
07613327624106 - Broadway 82025-02-03 Catheter
37613327548205 - Neptune SafeAir2025-01-14 Telescopic Smoke Evacuation Pencil, Push Button, Coated, No PVC
07613327273120 - TRIO2025-01-03 PEDICULAR SCREWDRIVER SHAFT
07613327273144 - TRIO +2025-01-03 SELF HOLDING PEDICULAR SCREWDRIVER
07613327273175 - TRIO +2025-01-03 FLEXIBLE EXTENDER III
07613327273182 - TRIO2025-01-03 ROD BENDER
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.