FDA.report

Nurse Cap O.R.

Primary DI
00616784211237
Brand
Nurse Cap O.R.
Company
DYNAREX CORPORATION
Model
2112
Device description
Nurse Cap O.R., 24", Green
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
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
00616784211237PackageGS15In Commercial Distribution
00616784211220PrimaryGS10
00616784211213Unit of UseGS10
00810180843096Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784211237006167842112376167842112370616784211237
00616784211220006167842112206167842112200616784211220
00616784211213006167842112136167842112130616784211213
00810180843096008101808430968101808430960810180843096

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
008124539
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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