FDA.report

CONVERTORS

Primary DI
50630140932609
Brand
CONVERTORS
Company
Cardinal Health 200, LLC
Model
8184N
Catalog number
8184N
Device description
Table Cover 48x90 BNS
Published
2016-06-21
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
KKXDrape, surgical
PUIDrape, surgical, exempt

Product Code Classifications

CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50630140932609PrimaryGS10
10630140932601Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5063014093260950630140932609
1063014093260110630140932601

GMDN Terms

TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

Regulatory Flags

DUNS number
961027315
Device count
1200
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
true
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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