CODMAN® MICROSENSOR®

Primary DI
10381780520320
Brand
CODMAN® MICROSENSOR®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
826605SP
Catalog number
82-6605SP
Device description
CODMAN® MICROSENSOR® Interface Control Unit
Published
2020-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWMDevice, monitoring, intracranial pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWMDevice, Monitoring, Intracranial PressureNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914479000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914479000MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCERCodman & Shurtleff, Inc.1994-03-07GWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780520320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178052032010381780520320

GMDN Terms#

Term, Definition table
TermDefinition
Intracerebral catheter cranial-fixation kitA collection of sterile devices intended to be used to affix an intracerebral sensor/infusion/drainage catheter on the skull of a patient. It includes cranial screws and screwing tools; it does not include the intracerebral catheter, and does not include devices intended for long-term implantation (> 30 days). This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
081277700
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

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