FDA.report

CONVERTORS

Primary DI
50885380052017
Brand
CONVERTORS
Company
Cardinal Health 200, LLC
Model
43476NS
Catalog number
43476NS
Device description
EENT Split Sheet BNS
Published
2016-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ERYDrape, surgical, ent
KKXDrape, surgical

Product Code Classifications

CodeDeviceSpecialtyClass
ERYDrape, Surgical, EntGeneral, Plastic Surgery2
KKXDrape, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50885380052017PrimaryGS10
10885380052019Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5088538005201750885380052017
1088538005201910885380052019

GMDN Terms

TermDefinition
ENT surgical drapeA protective covering made of natural or synthetic materials, or both, designed to isolate a surgical site from contamination (e.g., microbial, substance) during an ear/nose/throat (ENT) procedure. It will typically be shaped for this purpose. This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

Regulatory Flags

DUNS number
961027315
Device count
15
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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