FDA.reportPublic FDA data

HCS

Primary DI
10849027004588
Brand
HCS
Company
DYAD MEDICAL SOURCING, LLC
Model
HCS303XXLB
Device description
Lab Coat, Blue SMS w/Knit Cuffs and Collar, 5 Snap Closure, XX-Large
Published
2019-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
10849027004588PackageGS11In Commercial Distribution
00849027004581PrimaryGS10
20849027004585Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084902700458810849027004588
00849027004581008490270045818490270045810849027004581
2084902700458520849027004585

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/examination garment kitA collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078572603
Device count
25
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849027000149HCSHCS50062017-01-17
00849027000156HCSHCS50072017-01-17
00849027002587HCSHCS5006C2017-01-17
00849027001757HCSHCS11012019-12-31
00849027001764HCSHCS1101C2019-12-31
00849027001771HCSHCS11032019-12-31
00849027001788HCSHCS1103C2019-12-31
00849027001795HCSHCS11042019-12-31
00849027001801HCSHCS11052019-12-31
00849027001818HCSHCS11062019-12-31
00849027002846HCSHCS11022019-12-31
00849027005182HCSHCS11202021-01-31
00849027005199HCSHCS1120C2021-01-31
00849027005205HCSHCS11212021-01-31
00849027005212HCSHCS11222021-01-31
00849027005229HCSHCS1122C2021-01-31
00849027005236HCSHCS11232021-01-31
00849027005243HCSHCS11252021-01-31
00849027001740HCSHCS11002019-12-31
50849027001417HCSHCS3003XL2019-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00840456220955JMUJMU DENTAL, INCLYU2026-07-06
00840456220962JMUJMU DENTAL, INCLYU2026-07-06
00840456220979JMUJMU DENTAL, INCLYU2026-07-06
00840456220986JMUJMU DENTAL, INCLYU2026-07-06
00840456224328JMUJMU DENTAL, INCLYU2026-07-06
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10097604245002Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12