FDA.report

CARDINAL HEALTH

Primary DI
50195594508133
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
AMN6995101
Catalog number
AMN6995101
Device description
ADMISSION KIT
Published
2021-12-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LRPTRAY, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50195594508133PackageGS116In Commercial Distribution
10195594508135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559450813350195594508133
1019559450813510195594508135

GMDN Terms

TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. 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
false
No natural rubber latex
true
Sterilization required before use
false

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10198956258730CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956350205CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
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10198956482159CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956488533CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956491236CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956492592CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956492998CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956494824CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
04046826447953Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-03-24
04046826495923Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-03-24
04046826495978Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-03-24
50198956435382CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-24
50198956248968CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956284027CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956293043CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
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50198956305630CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956308433CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956313703CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
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50198956325607CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956331677CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956332292CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956348255CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
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