FDA.reportPublic FDA data

CustoMed

Primary DI
74895237141153
Brand
CustoMed
Company
KENPAX INTERNATIONAL LIMITED
Model
1
Catalog number
68-331B-NC
Device description
Surgical capA 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.
Published
2020-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
84895237141150PackageGS1500In Commercial Distribution
74895237141153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8489523714115084895237141150
7489523714115374895237141153

GMDN Terms#

Term, Definition table
TermDefinition
Surgical cap, single-useA 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 may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device.

Regulatory Flags#

DUNS number
686206765
Device count
1
Premarket exempt
true
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
74895237104134CustoMed168-324B-PC2020-07-16
74895237141146CustoMed168-321G-PC2020-07-16
74895237141450SOURCE SURGICAL INC.168-2210-W2021-03-15
74895237141467SOURCE SURGICAL INC.168-2220-W2021-03-15
74895237104110Customed168-101B-UC2020-07-16
74895237108019SURGIPLUS168-7171-B2020-07-22
74895237108026SURGIPLUS168-7172-B2020-07-22
74895237108033SURGIPLUS168-7173-B2020-07-22
74895237108040SURGIPLUS168-7174-B2020-07-22
74895237108057SURGIPLUS168-7175-B2020-07-22
74895237108071SURGIPLUS168-7177-B2020-07-29
74895237108088SURGIPLUS168-7176-B2020-07-22
74895237108095SURGIPLUS168-7178-B2020-07-29
74895237141474SOURCE SURGICAL INC.168-3230-B2021-03-15
74895237141528SURGIPLUS168-6148-B2021-03-15
74895237141535SURGIPLUS168-6149-B2021-03-15
04895237141161CustoMed110030922020-07-16
04895237141178CustoMed110042922020-07-16
04895237141185CustoMed110042932020-07-16
04895237141192CustoMed11007802020-07-16

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