FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756201075
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
50-7915
Catalog number
50-7915
Device description
N/S EXPOSURE CONTROL KIT-10/C
Published
2021-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
50749756201075PackageGS110In Commercial Distribution
00749756201070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975620107550749756201075
00749756201070007497562010707497562010700749756201070

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

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
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20809160388997Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2022-11-09
20809160365936Therma SolutionsMEDICAL ACTION INDUSTRIES INC.OKH2022-02-16
50749756915613DeRoyalDEROYAL INDUSTRIES, INC.OKH2021-08-23
25060498452155Motion Medical DistributingHaslam Medical, Inc.OKH2021-02-15
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
20809160274030Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-12-13
20809160269098medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-11-01
20809160267025Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-10-16
20809160266882HalyardMEDICAL ACTION INDUSTRIES INC.OKH2019-10-14
20809160266899HALYARDMEDICAL ACTION INDUSTRIES INC.OKH2019-10-14
20809160261894Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-09-16
00815277028790CuraplexBOUND TREE MEDICAL, LLCOKH2018-12-15
00815277029544CuraplexBOUND TREE MEDICAL, LLCOKH2018-12-15
00815277029551CuraplexBOUND TREE MEDICAL, LLCOKH2018-12-15
00817617028675CuraplexBOUND TREE MEDICAL, LLCOKH2017-10-13
00817617028682CuraplexBOUND TREE MEDICAL, LLCOKH2017-10-13
00817617028699CuraplexBOUND TREE MEDICAL, LLCOKH2017-10-13
00817617028705CuraplexBOUND TREE MEDICAL, LLCOKH2017-10-13
20809160165871Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2017-10-09
00817617027722CuraplexBOUND TREE MEDICAL, LLCOKH2017-07-27
25060498451547Motion Medical DistributingHaslam Medical, Inc.OKH2017-06-13
25060498451516Motion Medical DistributingHaslam Medical, Inc.OKH2017-06-06
25060498451523Motion Medical DistributingHaslam Medical, Inc.OKH2017-06-06
20809160145484Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2017-04-21
25060498451349Motion Medical DistributingHaslam Medical, Inc.OKH2017-02-28
00815277020077CuraplexBOUND TREE MEDICAL, LLCOKH2016-12-14
00815277020169CuraplexBOUND TREE MEDICAL, LLCOKH2016-12-14