BACTISEAL 823087

GUDID 10886704072676

BEVC BACTISEAL Endoscopic Ventricular Catheter Includes: Ventricular Catheter 14cm (1), Right Angle Adaptor (1), Information manual (1)

CODMAN & SHURTLEFF, INC.

Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term
Primary Device ID10886704072676
NIH Device Record Keyb1cbdae1-2969-4c50-8219-352ea6feb763
Commercial Distribution StatusIn Commercial Distribution
Brand NameBACTISEAL
Version Model Number82-3087
Catalog Number823087
Company DUNS607846297
Company NameCODMAN & SHURTLEFF, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
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(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Operating and Storage Conditions

Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110886704072676 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXGShunt, central nervous system and components

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-07-22
Device Publish Date2015-09-20

On-Brand Devices [BACTISEAL]

10886704072683BEVC KIT BACTISEAL Endoscopic Ventricular Catheter and Distal Catheter Kit Includes: Ventricular
10886704072676BEVC BACTISEAL Endoscopic Ventricular Catheter Includes: Ventricular Catheter 14cm (1), Right An

Trademark Results [BACTISEAL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BACTISEAL
BACTISEAL
75612666 2729431 Live/Registered
INTEGRA LIFESCIENCES CORPORATION
1998-12-28
BACTISEAL
BACTISEAL
74553219 not registered Dead/Abandoned
JOHNSON & JOHNSON
1994-07-25

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.