FDA.report

CARDINAL HEALTH

Primary DI
50195594954930
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOTCGPPME2
Catalog number
SOTCGPPME2
Device description
IUS PERC 1 PK
Published
2021-03-10
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
PPENephroscope set

Product Code Classifications

CodeDeviceSpecialtyClass
PPENephroscope SetGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50195594954930PackageGS12In Commercial Distribution
10195594954932PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559495493050195594954930
1019559495493210195594954932

GMDN Terms

TermDefinition
Nephroscopic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical and endoscopic instruments, dressings and the necessary materials used to perform a nephroscopic surgical procedure. It 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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