FDA.report

CARDINAL HEALTH

Primary DI
50197106769834
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA55GLKVA
Catalog number
SMA55GLKVA
Device description
GYN LAP PACK
Published
2024-10-08
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
OHAHeart valve, more than minimally manipulated allograft

Product Code Classifications

CodeDeviceSpecialtyClass
OHAHeart Valve, More Than Minimally Manipulated AllograftUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50197106769834PackageGS13In Commercial Distribution
10197106769836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019710676983450197106769834
1019710676983610197106769836

GMDN Terms

TermDefinition
Laparoscopic surgical procedure kit, non-medicated, single-useA collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a single-use device.

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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