FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756565462
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
89-3812
Device description
BARRIER PROTECTION KIT
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OKHBody fluids barrier kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKHBody Fluids Barrier KitGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756565467PackageGS130In Commercial Distribution
00749756565462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975656546750749756565467
00749756565462007497565654627497565654620749756565462

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.

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756402545DeRoyal25-0103EU25-0103EU2026-07-08
00749756402552DeRoyal25-0103EUN25-0103EUN2026-07-08
00749756402569DeRoyal25-0104EU25-0104EU2026-07-08
00749756402576DeRoyal25-0104EUN25-0104EUN2026-07-08
00749756402583DeRoyal25-0105EU25-0105EU2026-07-08
00749756402590DeRoyal25-0108EU25-0108EU2026-07-08
00749756402606DeRoyal25-0201EU25-0201EU2026-07-08
00749756402613DeRoyal25-0401EU25-0401EU2026-07-08
00749756402620DeRoyal25-0401EUN25-0401EUN2026-07-08
00749756402637DeRoyal25-0402EU25-0402EU2026-07-08
00749756402644DeRoyal25-0402EUN25-0402EUN2026-07-08
00749756402651DeRoyal25-0403EU25-0403EU2026-07-08
00749756402675DeRoyal25-0801EU25-0801EU2026-07-08
00749756402682DeRoyal25-0802EU25-0802EU2026-07-08
00749756402712DeRoyal25-1108EU25-1108EU2026-07-08
00749756402729DeRoyal25-1108EUN25-1108EUN2026-07-08
00749756402736DeRoyal25-1401EU25-1401EU2026-07-08
00749756402743DeRoyal25-1401EUN25-1401EUN2026-07-08
00749756402774DeRoyal25-1403EUN25-1403EUN2026-07-08
00749756402538DeRoyal25-0101EUN25-0101EUN2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160388990Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2022-11-09
20809160388997Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2022-11-09
10809160365939Therma SolutionsMEDICAL ACTION INDUSTRIES INC.OKH2022-02-16
20809160365936Therma SolutionsMEDICAL ACTION INDUSTRIES INC.OKH2022-02-16
00810071632402CuraplexBOUND TREE MEDICAL, LLCOKH2021-09-30
00749756915618DeRoyalDEROYAL INDUSTRIES, INC.OKH2021-08-23
50749756915613DeRoyalDEROYAL INDUSTRIES, INC.OKH2021-08-23
00749756201070DeRoyalDEROYAL INDUSTRIES, INC.OKH2021-07-12
50749756201075DeRoyalDEROYAL INDUSTRIES, INC.OKH2021-07-12
15060498452158Motion Medical DistributingHaslam Medical, Inc.OKH2021-02-15
25060498452155Motion Medical DistributingHaslam Medical, Inc.OKH2021-02-15
15060498452097Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
15060498452103Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
15060498452110Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
15060498452127Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
25060498452094Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
25060498452100Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
25060498452117Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
25060498452124Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
10809160274033Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-12-13
20809160274030Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-12-13
10809160272589Medical Action Industries IncMEDICAL ACTION INDUSTRIES INC.OKH2019-11-22
10809160269091medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-11-01
20809160269098medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-11-01
10809160267028Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-10-16
20809160267025Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-10-16
10809160266885HalyardMEDICAL ACTION INDUSTRIES INC.OKH2019-10-14
10809160266892HALYARDMEDICAL ACTION INDUSTRIES INC.OKH2019-10-14
20809160266882HalyardMEDICAL ACTION INDUSTRIES INC.OKH2019-10-14
20809160266899HALYARDMEDICAL ACTION INDUSTRIES INC.OKH2019-10-14