FDA.report

CARDINAL HEALTH

Primary DI
50195594468048
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA48BTBC7
Catalog number
SBA48BTBC7
Device description
BIOPSY SET UP TRAY FOR CT PACK
Published
2021-12-09
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
OFGCT biopsy tray

Product Code Classifications

CodeDeviceSpecialtyClass
OFGCt Biopsy TrayCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50195594468048PackageGS112In Commercial Distribution
10195594468040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559446804850195594468048
1019559446804010195594468040

GMDN Terms

TermDefinition
Cardiothoracic surgical procedure kit, medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device intended to be sterilized prior to use.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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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