FDA.reportPublic FDA data

SURGIPLUS

Primary DI
74895237108088
Brand
SURGIPLUS
Company
KENPAX INTERNATIONAL LIMITED
Model
1
Catalog number
68-7176-B
Device description
Scrub Pant, 2XLA non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.
Published
2020-07-22
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
84895237108061PackageGS160In Commercial Distribution
74895237108088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8489523710806184895237108061
7489523710808874895237108088

GMDN Terms#

Term, Definition table
TermDefinition
Scrub suit, single-useA two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.

Regulatory Flags#

DUNS number
686206765
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
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
74895237141153CustoMed168-331B-NC2020-07-16
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
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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