FDA.report

CARDINAL HEALTH

Primary DI
50195594817037
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN11OSJH9
Catalog number
SEN11OSJH9
Device description
ORAL SURGERY PACK
Published
2022-09-09
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
PWLOral Surgery Tray

Product Code Classifications

CodeDeviceSpecialtyClass
PWLOral Surgery TrayDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50195594817037PackageGS13In Commercial Distribution
10195594817039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559481703750195594817037
1019559481703910195594817039

GMDN Terms

TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, single-useA collection of various sterile dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any 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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