FDA.report

CARDINAL HEALTH

Primary DI
50885380144729
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
3287
Catalog number
3287
Device description
CAP BOUFFANT OD 27IN COMFORTABLE BLUE
Published
2018-11-14
Public version status
New
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
FYFCAP, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
FYFCap, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50885380144729PackageGS110In Commercial Distribution
20885380144728PrimaryGS10
10885380144721Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5088538014472950885380144729
2088538014472820885380144728
1088538014472110885380144721

GMDN Terms

TermDefinition
Surgical cap, single-useA non-sterile head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is usually made of reinforced paper or non-woven materials. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
75
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
true
Sterilization required before use
false

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