FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756026326
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
30-0202
Device description
C-Arm Drape
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MMPCover, barrier, protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMPCover, Barrier, ProtectiveGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756026326PackageGS120In Commercial Distribution
00749756026321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975602632650749756026326
00749756026321007497560263217497560263210749756026321

GMDN Terms#

Term, Definition table
TermDefinition
C-arm drapeA sterile device intended to cover/wrap the C-arm and/or mini C-arm of a mobile or stationary fluoroscopic x-ray system and function as a physical barrier to prevent cross-contamination between the C-arm and the surgical staff/field during a procedure. It is typically made of flexible plastic and shaped to fit the C-arm; it is available in various sizes. 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
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00814707023817ProtekASPEN SURGICAL PRODUCTS, INC.MMP2026-02-16
00850061871053IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMP2024-10-23
00850061871039IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMP2024-10-22
40193489130226COLABELMEDLINE INDUSTRIES, INC.MMP2024-04-11
40884389413631Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
40884389413648Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
40884389614601Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
40195327422203Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-06-04
10193489189223MedlineMEDLINE INDUSTRIES, INC.MMP2022-11-10
40080196900702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489469456Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489490498Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771443Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771467Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771474Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771481Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771498Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327052585Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327057405Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327057658Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327057665Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327060085Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
M7521001NS1Stradis Medical, LLC.STRADIS MEDICAL, LLCMMP2022-04-26
10810050854174Typenex Extubation BibTYPENEX MEDICAL LLCMMP2022-04-04
00850977007881IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMP2021-12-14
40195327004409Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2021-10-03
10193489400625Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2021-07-04
40193489437127MedlineMEDLINE INDUSTRIES, INC.MMP2021-02-11
20888277677972MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMP2021-01-29
40080196073161MedlineMEDLINE INDUSTRIES, INC.MMP2020-12-31