BACTISEAL® NS5525

GUDID 10381780526803

Ventricular Catheter with centimeter markings with BACTISEAL Shunt System. Contents: BACTISEAL Ventricular Catheter 14cm (1), Stylet (1), RA Adapter (1), Information manual (1)

INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term
Primary Device ID10381780526803
NIH Device Record Key69ee4f6f-3929-47f1-937f-23b47e04da2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBACTISEAL®
Version Model NumberNS5525
Catalog NumberNS5525
Company DUNS081277700
Company NameINTEGRA LIFESCIENCES PRODUCTION CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780526803 [Primary]
GS110381780526803 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HCACATHETER, VENTRICULAR
HCACATHETER, VENTRICULAR

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

On-Brand Devices [BACTISEAL®]

1038178052550923cm Ventricular Catheter Set Includes: Ventricular Catheter, Stylet, Luer Connector, Cap, Cathe
10381780525363Catheter Set Includes: 35cm Ventricular Catheter, 1mm Stylet, Connector, Cap, Catheter Anchoring
10381780525271Catheters Includes: Barium Ventricular Catheter 15cm, Stylet, Barium Peritonal Catheter, Right A
10381780525264Catheter Includes: Barium Peritoneal Catheter 120cm and Information Manual
10381780525257Large Ventricular Catheter Includes: Barium Ventricular Catheter 15cm, Stylet, Right Angle Adapt
1038178052409020cm Ventricular Catheter Set Includes: 20cm Catheter with Stylet, Connector, Cap, Catheter Anch
1038178052408323cm Ventricular Catheter Includes: Stylet, Right Angle Adapter and Information Manual
10381780524076Clear with Barium Stripe Catheter Kit Includes: Clear with Barium Stripe Distal Catheter 120cm,
10381780524069Clear with Barium Stripe Distal Catheter, 120cm Includes: Information Manual
10381780524052Clear with Barium Stripe Ventricular Catheter, 15cm Includes: Stylet, Right Angle Adapter and In
10381780519034BEVC KIT Endoscopic Ventricular Catheter and Distal Catheter Kit Includes: Ventricular Catheter
10381780519027BEVC Endoscopic Ventricular Catheter Includes: Ventricular Catheter 14cm (1), Right Angle Adapto
10381780518457Clear Catheter 1.9mm I.D. Catheter Set Includes: 35cm Ventricular Catheter, Stylet, Connector, C
103817805184401.9mm I.D. Catheter Set Includes 35cm Ventricular Catheter, Stylet, Connector, Cap, Catheter Anc
10381780515630Distal Catheter Kit with Shunt System Contents: Distal Catheter 120cm (1), information manual (1
10381780515623Ventricular Catheter with Shunt System Contents: Ventricular Catheter 14cm (1), Stylet (1), RA A
10381780515616Ventricular Catheter and Distal Catheter Kit with Shunt System Contents: Ventricular Catheter 14
10381780515593Catheter Set Includes 35cm Ventricular Catheter, Stylet, Connector, Cap, Catheter Anchoring Clip
10381780526803Ventricular Catheter with centimeter markings with BACTISEAL Shunt System. Contents: BACTISEAL

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