FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756915618
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
89-9587
Catalog number
89-9587
Device description
U DRAPE PACK
Published
2021-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50749756915613PackageGS18In Commercial Distribution
00749756915618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975691561350749756915613
00749756915618007497569156187497569156180749756915618

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
00749756389181DeRoyal81-1020SU81-1020SU2026-09-21
00749756389204DeRoyal81-1020REF81-1020REF2026-09-21
00749756399258DeRoyal46-326XBNS46-326XBNS2026-09-21
00749756400442DeRoyal77-40111877-4011182026-09-21
00749756985475DeRoyalNP-790NP-7902026-09-21
00749756985963DeRoyalNP-7300-01NP-7300-012026-09-21
00749756985994DeRoyalNP-7300NP-73002026-09-21
00749756986250DeRoyalNP-7300NNP-7300N2026-09-21
00749756394666DeRoyal47-820KG47-820KG2026-09-18
00749756397193DeRoyal47-813KG-0147-813KG-012026-09-18
00749756397339DeRoyal15410002154100022026-09-18
00749756397346DeRoyal15410003154100032026-09-18
00749756400800DeRoyal32-219532-21952026-09-18
00749756401289DeRoyalNP-7000-GPSNP-7000-GPS2026-09-18
00749756401678DeRoyal13-809A-01-COSM13-809A-01-COSM2026-09-18
00749756401692DeRoyalNP-6007U-01NP-6007U-012026-09-18
00749756401708DeRoyal46-LB19546-LB1952026-09-18
00749756401715DeRoyal46-LB38546-LB3852026-09-18
00749756401739DeRoyalM60-SF510TM60-SF510T2026-09-18
00749756401746DeRoyalNP-120UNP-120U2026-09-18

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
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
10809160261897Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-09-16