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
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
00810178887743ViveVIVE HEALTH LLCLKB2026-08-07
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