FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756371285
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
31-705
Catalog number
31-705
Device description
Alcohol Prep Pad
Published
2021-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKBPad, alcohol, device disinfectant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKBPad, Alcohol, Device DisinfectantUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756371280PackageGS1800In Commercial Distribution
00749756371285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975637128050749756371280
00749756371285007497563712857497563712850749756371285

GMDN Terms#

Term, Definition table
TermDefinition
Skin-cleaning wipe, sterileA sterile device consisting of an absorbent fabric pre-soaked in a liquid solution (e.g. a detergent, alcohol, saline) intended for cleaning a localized body surface before a procedure or device application, and/or to maintain skin hygiene. It is commonly known as a wet wipe and is intended for use in the home or healthcare facility. 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
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
06977236460028PEVIVINWenzhou Qingcheng Healthcare Tech Ltd.LKB2026-06-23
50192253047088WebcolCardinal Health 200, LLCLKB2025-10-16
10192253045741WebcolCardinal Health 200, LLCLKB2025-09-29
50192253045749WebcolCardinal Health 200, LLCLKB2025-09-29
10192253047073WebcolCardinal Health 200, LLCLKB2025-07-28
50192253047071WebcolCardinal Health 200, LLCLKB2025-07-28
50192253045725WebcolCardinal Health 200, LLCLKB2025-06-12
10192253045727WebcolCardinal Health 200, LLCLKB2025-06-12
10192253047066WebcolCardinal Health 200, LLCLKB2025-06-10
20192253047063WebcolCardinal Health 200, LLCLKB2025-06-10
00860000526517True Comfort Alcohol PadsHOME AIDE DIAGNOSTICS, INC.LKB2024-10-08
10860000526514True Comfort Alcohol PadsHOME AIDE DIAGNOSTICS, INC.LKB2024-10-08
10192253046205WebcolCardinal Health 200, LLCLKB2024-09-05
10653160373858MEDLINEMEDLINE INDUSTRIES, INC.LKB2024-04-25
00653160373851MEDLINEMEDLINE INDUSTRIES, INC.LKB2024-04-25
00310819000031Prevantics® Device Large Swab PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.LKB2024-02-15
10850049784532SURGYCOSurgyco LLCLKB2023-12-15
10850049784556SURGYCOSurgyco LLCLKB2023-12-15
20850049784539SURGYCOSurgyco LLCLKB2023-12-15
20850049784553SURGYCOSurgyco LLCLKB2023-12-15
10801741086936SITE-SCRUBBard Access Systems, Inc.LKB2023-12-13
10801741086943SITE-SCRUBBard Access Systems, Inc.LKB2023-12-13
00801741086939SITE-SCRUBBard Access Systems, Inc.LKB2023-12-13
00801741086946SITE-SCRUBBard Access Systems, Inc.LKB2023-12-13
50192253047095WebcolCardinal Health 200, LLCLKB2023-10-09
10192253047097WebcolCardinal Health 200, LLCLKB2023-10-09
00326053104770Regard™Resource Optimization & Innovation, L.L.C.LKB2023-08-08
06972403307571ZDXuchang Zhende Surgical Dressing Co., Ltd.LKB2023-06-28
06972403307564ZDXuchang Zhende Surgical Dressing Co., Ltd.LKB2023-06-28
00810132040788HCSConcordance Healthcare Solutions LLCLKB2023-05-01