FDA.report

DeRoyal

Primary DI
00749756833936
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
13-804A-04
Catalog number
13-804A-04
Device description
EDEMA GLOVE
Published
2021-07-20
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

Related Records

Contact Domains

Product Codes

CodeName
MHWDRESSING, COMPRESSION

Product Code Classifications

CodeDeviceSpecialtyClass
MHWDressing, CompressionGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00749756833936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756833936007497568339367497568339360749756833936

GMDN Terms

TermDefinition
Compression/pressure gloveA device in the form of a short or long glove intended to tightly fit over the hand(s) to apply compression/pressure (i.e., graduated or even-force), typically to control oedema, swelling and/or scarring due to arthritis or injuries, and/or to manage lymphoedema; it is not a strip/roll binder, shirt or tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex) and may be available with openings for fingers and/or with integrated sleeves that may reach the wrist, elbow, or axilla; it does not include antimicrobial features. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags

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

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
00851587006097AirWrap XLRevmedx, Inc.MHW2026-02-25
00810178886890ViveVIVE HEALTH LLCMHW2026-02-17
00810178886906ViveVIVE HEALTH LLCMHW2026-02-17
00810178886913ViveVIVE HEALTH LLCMHW2026-02-17
00810178886920ViveVIVE HEALTH LLCMHW2026-02-17
00810178886937ViveVIVE HEALTH LLCMHW2026-02-17
00810178886944ViveVIVE HEALTH LLCMHW2026-02-17
00810178886951ViveVIVE HEALTH LLCMHW2026-02-17
00810178886968ViveVIVE HEALTH LLCMHW2026-02-17
00810178886975ViveVIVE HEALTH LLCMHW2026-02-17
00810178886982ViveVIVE HEALTH LLCMHW2026-02-17
00810178886999ViveVIVE HEALTH LLCMHW2026-02-17
00810178887002ViveVIVE HEALTH LLCMHW2026-02-17
00810178887019ViveVIVE HEALTH LLCMHW2026-02-17
00810178887026ViveVIVE HEALTH LLCMHW2026-02-17
00810178887033ViveVIVE HEALTH LLCMHW2026-02-17
16974600043396KONLIDASuzhou Konlida Medical Supplies Co., Ltd.MHW2025-07-28
16974600043402KONLIDASuzhou Konlida Medical Supplies Co., Ltd.MHW2025-07-28
00884450828755SAFEGUARD FOCUS COOL™Merit Medical Systems, Inc.MHW2025-07-01
M68932700070BATTLE BANDAGESafeguard US Operating, LLCMHW2025-03-26
00884450844243SAFEGUARD FOCUS COOL™Merit Medical Systems, Inc.MHW2025-03-07
00884450828748SAFEGUARD FOCUS™Merit Medical Systems, Inc.MHW2025-01-01
00850051939565AeroWrap™ Full LegSUN SCIENTIFIC, INC.MHW2024-12-05
00850051939572AeroWrap™ Full LegSUN SCIENTIFIC, INC.MHW2024-12-05
00850051939589AeroWrap™ Full LegSUN SCIENTIFIC, INC.MHW2024-12-05
00850051939596AeroWrap™ Full LegSUN SCIENTIFIC, INC.MHW2024-12-05
00850051939602AeroWrap™ Full LegSUN SCIENTIFIC, INC.MHW2024-12-05
00850051939619AeroWrap™ Full LegSUN SCIENTIFIC, INC.MHW2024-12-05
00850051939626AeroWrap™ Full LegSUN SCIENTIFIC, INC.MHW2024-12-05
00850051939640AeroWrap™ Full LegSUN SCIENTIFIC, INC.MHW2024-12-05