FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594790200
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN29BRCC8
Catalog number
SAN29BRCC8
Device description
BRACHYTHERAPY PACK
Published
2022-08-19
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
OINProstate seeding kit

Product Code Classifications

CodeDeviceSpecialtyClass
OINProstate Seeding KitRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50195594790200PackageGS14In Commercial Distribution
10195594790202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559479020050195594790200
1019559479020210195594790202

GMDN Terms

TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature040 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
true
No natural rubber latex
false
Sterilization required before use
false

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10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
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