FDA.reportPublic FDA data

CustoMed

Primary DI
74895237141078
Brand
CustoMed
Company
KENPAX INTERNATIONAL LIMITED
Model
1
Catalog number
68-567W-LC
Device description
Lab coat
Published
2020-07-06
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
84895237141075PackageGS125In Commercial Distribution
74895237141078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8489523714107584895237141075
7489523714107874895237141078

GMDN Terms#

Term, Definition table
TermDefinition
Exploratory blunt needle, single-useA sterile, slender, hand-held manual instrument designed with a dull curved tip intended to prevent damage to sensitive and delicate tissues while it is being used to explore within the body. This is a single-use device.

Regulatory Flags#

DUNS number
686206765
Device count
1
Premarket exempt
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756401753DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00749756401760DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00749756401777DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00749756401784DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00850078013101MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013118MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013125MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013132MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013149MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00840456224571JMUJMU DENTAL, INCLYU2026-08-18
00840456224588JMUJMU DENTAL, INCLYU2026-08-18
00840456224595JMUJMU DENTAL, INCLYU2026-08-18
00840456224601JMUJMU DENTAL, INCLYU2026-08-18
00840456224618JMUJMU DENTAL, INCLYU2026-08-18
00840456218402JMUJMU DENTAL, INCLYU2026-07-06
00840456218419JMUJMU DENTAL, INCLYU2026-07-06
00840456218426JMUJMU DENTAL, INCLYU2026-07-06
00840456218433JMUJMU DENTAL, INCLYU2026-07-06
00840456218440JMUJMU DENTAL, INCLYU2026-07-06
00840456218457JMUJMU DENTAL, INCLYU2026-07-06
00840456218464JMUJMU DENTAL, INCLYU2026-07-06
00840456218471JMUJMU DENTAL, INCLYU2026-07-06
00840456218488JMUJMU DENTAL, INCLYU2026-07-06
00840456218495JMUJMU DENTAL, INCLYU2026-07-06
00840456220894JMUJMU DENTAL, INCLYU2026-07-06
00840456220900JMUJMU DENTAL, INCLYU2026-07-06
00840456220917JMUJMU DENTAL, INCLYU2026-07-06
00840456220924JMUJMU DENTAL, INCLYU2026-07-06
00840456220931JMUJMU DENTAL, INCLYU2026-07-06
00840456220948JMUJMU DENTAL, INCLYU2026-07-06