CARDINAL HEALTH

Primary DI
50197106545117
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE81ACA13
Catalog number
SNE81ACA13
Device description
ACH CRANI
Published
2024-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OJAIntravenous extension tubing set

Product Code Classifications

CodeDeviceSpecialtyClass
OJAIntravenous Extension Tubing SetGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50197106545117PackageGS12In Commercial Distribution
10197106545119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019710654511750197106545117
1019710654511910197106545119

GMDN Terms

TermDefinition
Craniotomy kitA collection of various sterile basic instruments, dressings and the necessary materials used to perform a craniotomy procedure. It typically includes scalpels, retractors, forceps, sutures, but does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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