FDA.reportPublic FDA data

CODMAN®

Primary DI
10381780511540
Brand
CODMAN®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
161055
Catalog number
16-1055
Device description
CODMAN® SOOTT Ventricular Cannula Disposable 8Fr. 1.3mm I D x 2.5mm O D 80mm
Published
2020-04-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCACATHETER, VENTRICULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCACatheter, VentricularNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K834477000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K834477000DISPOS. SCOTT CANNULAS 16-1054 ETC.Codman & Shurtleff, Inc.1984-03-19HCA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780511540PrimaryGS10
00381780511543Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178051154010381780511540
00381780511543003817805115433817805115430381780511543

GMDN Terms#

Term, Definition table
TermDefinition
Intracerebral cannula, nonimplantable, reusableA nonimplantable, rigid tube intended to be surgically inserted through the skull to access the brain (e.g., cerebral ventricles) for cerebrospinal fluid (CSF) drainage, infusion of materials, and/or for use as a port through which instruments, leads and/or probes can be passed to perform a variety of diagnostic, treatment, or surgical procedures. It is usually made of metal (e.g., stainless steel) and may include a stylet/trocar blade. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French
Device Size Text, specify0
Length80Millimeter
Outer Diameter2.5Millimeter

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
5
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780535393CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2024-11-20
10381780535430CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2024-11-20
10381780535829CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2024-11-20
10381780535805CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2024-11-20
10381780535843CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2024-11-20
10381780535867CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2024-11-20
10381780536970CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780536987CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780536994CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537007CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537014CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537021CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537038CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537045CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537052CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537069CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537076CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537083CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537090CODMAN® HAKIM® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537106CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537113CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537120CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537137CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537144CODMAN® HAKIM® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
10381780537151CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2024-11-20
00763000028961Innervision, BioGlide®MEDTRONIC PS MEDICAL, INC.HCA2020-08-21
00763000333614Exacta™MEDTRONIC PS MEDICAL, INC.HCA2020-06-08
10381780521136CODMAN CERTAS® PlusIntegra LifeSciences Switzerland SàrlHCA2020-06-03
10381780526803CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2020-05-11
10381780511557CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHCA2020-04-01