FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756552733
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
46-333
Catalog number
46-333
Device description
DeWRAP 3LYR COMPRESSION
Published
2023-02-02
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

Product Codes#

Code, Name table
CodeName
MHWDressing, compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHWDressing, CompressionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756552733PackageGS18In Commercial Distribution
00749756552738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975655273350749756552733
00749756552738007497565527387497565527380749756552738

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, non-latex, single-useA strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756401944DeRoyal46-LT5S-0546-LT5S-052026-05-14
00749756998857DeRoyal99-021399-02132019-11-09
00749756998864DeRoyal99-021499-02142019-11-09
00749756998871DeRoyal99-021599-02152019-11-09
00749756998888DeRoyal99-021699-02162019-11-09
00749756998901DeRoyal99-021799-02172019-11-09
00749756998918DeRoyal99-021899-02182019-11-09
00749756998925DeRoyal99-021999-02192019-11-09
00749756998956DeRoyal99-022099-02202019-11-09
00749756998963DeRoyal99-022199-02212019-11-09
00749756998970DeRoyal99-022299-02222019-11-09
00749756998642DeRoyal99-021199-02112021-05-07
00749756401685DeRoyalNP-7DAYKITUTSNP-7DAYKITUTS2026-04-02
00749756401951DeRoyal46-LT20S-0446-LT20S-042026-04-02
00749756401968DeRoyal46-LT19S-0446-LT19S-042026-04-02
00749756402033DeRoyal46-LB5546-LB552026-04-02
00749756879699DeRoyal1104SPP1104SPP2026-04-02
00749756879705DeRoyal1104MPP1104MPP2026-04-02
00749756879712DeRoyal1104LPP1104LPP2026-04-02
00749756879729DeRoyal1104XLPP1104XLPP2026-04-02

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Primary DI, Brand, Company table
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M68931150030TQ™ RAMSafeguard US Operating, LLCMHW2025-01-29
10884450828745SAFEGUARD FOCUS™Merit Medical Systems, Inc.MHW2025-01-01
10193489084658MEDLINEMEDLINE INDUSTRIES, INC.MHW2024-09-13
00810041983572ViveVIVE HEALTH LLCMHW2024-06-07
00810041983589ViveVIVE HEALTH LLCMHW2024-06-07
00810041983596ViveVIVE HEALTH LLCMHW2024-06-07
00810041983602ViveVIVE HEALTH LLCMHW2024-06-07
00810041983619ViveVIVE HEALTH LLCMHW2024-06-07
00810041982087ViveVIVE HEALTH LLCMHW2024-06-05
00840117327825"Sensi Wrap,Self-Adherent - Latex Free 2 x 5"" yds Green"Dynarex CorporationMHW2023-12-20
00840117327849"Sensi Wrap,Self-Adherent - Latex Free 2 x 5"" yds Light Blue"Dynarex CorporationMHW2023-12-20
00840117327863"Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yds Purple "Dynarex CorporationMHW2023-12-20
00840117327887"Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yd Pink"Dynarex CorporationMHW2023-12-20
00840117327900"Sensi Wrap,Self-Adherent - Latex Free 3"" x 5 yds Red"Dynarex CorporationMHW2023-12-20
00840117327924"Sensi Wrap,Self-Adherent - Latex Free 3"" x 5 yds Green"Dynarex CorporationMHW2023-12-20
00840117327726"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Green"Dynarex CorporationMHW2023-12-17
00840117327740"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Blue"Dynarex CorporationMHW2023-12-17
00840117327764"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Purple "Dynarex CorporationMHW2023-12-17
00840117327788"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Pink"Dynarex CorporationMHW2023-12-17
00840117327801"Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yd Red "Dynarex CorporationMHW2023-12-17
10811331010173Comfort BandTz Medical, Inc.MHW2023-10-20
10811331010180Comfort BandTz Medical, Inc.MHW2023-10-20
00810113571249ViveVIVE HEALTH LLCMHW2023-08-07
00810113571256ViveVIVE HEALTH LLCMHW2023-08-07
00810113571959ViveVIVE HEALTH LLCMHW2023-08-07
00810113571966ViveVIVE HEALTH LLCMHW2023-08-07
00810113571973ViveVIVE HEALTH LLCMHW2023-08-07