FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756028993
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
35-404
Catalog number
35-404
Device description
Esmark
Published
2021-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAXTOURNIQUET, NONPNEUMATIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756028993PackageGS120In Commercial Distribution
00749756028998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975602899350749756028993
00749756028998007497560289987497560289980749756028998

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, non-latex, single-useA strip or roll of fabric or plastic material (non-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

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
10842942010894PRIMEDpriMED Medical Products IncGAX2026-03-03
10810132043410HCSConcordance Healthcare Solutions LLCGAX2025-12-05
10810132043427HCSConcordance Healthcare Solutions LLCGAX2025-12-05
10810132043434HCSConcordance Healthcare Solutions LLCGAX2025-12-05
10810132043441HCSConcordance Healthcare Solutions LLCGAX2025-12-05
10810132043458HCSConcordance Healthcare Solutions LLCGAX2025-12-05
10810132043465HCSConcordance Healthcare Solutions LLCGAX2025-12-05
00850063404396easycareSynchronis Medical, LLCGAX2025-12-05
00842209136636NARNORTH AMERICAN RESCUE, LLCGAX2025-11-24
00842209136643NARNORTH AMERICAN RESCUE, LLCGAX2025-11-24
07290012685477HemaClearONEG HAKARMEL LTDGAX2025-09-29
07290012685491HemaClearONEG HAKARMEL LTDGAX2025-09-29
07290020471000T.A.L Tactical Aid Lifesaver SINGER INSTRUMENTS & CONTROL LTD.GAX2025-09-25
00860003436424Multi-TENTROTECH LIFE SCIENCES, LLCGAX2025-06-30
00860003436455Multi-TENTROTECH LIFE SCIENCES, LLCGAX2025-06-30
00869193000040T-RING FLEX Digit TourniquetPRECISION MEDICAL DEVICES, LLCGAX2025-06-11
10869193000016T-RING Digit TourniquetPRECISION MEDICAL DEVICES, LLCGAX2025-06-10
08057592700025TOURNIK-ITFLAMOR SRLGAX2025-05-28
08057592700032TOURNIK-ITFLAMOR SRLGAX2025-05-28
08057592700049TOURNIK-ITFLAMOR SRLGAX2025-05-28
10661392011677LSL HEALTHCARELSL Industries, LLCGAX2025-05-16
10661392011691LSL HEALTHCARELSL Industries, LLCGAX2025-05-16
10661392053585LSL HEALTHCARELSL Industries, LLCGAX2025-05-16
30665973032390DukalDukal LLCGAX2025-04-08
30665973032406DukalDukal LLCGAX2025-04-08
00840490800007PRESTIGEPROPRESTIGE AMERITECH, LTD.GAX2025-04-04
10840490800011PRESTIGEPROPRESTIGE AMERITECH, LTD.GAX2025-04-04
10840490800028PRESTIGEPROPRESTIGE AMERITECH, LTD.GAX2025-04-04
10840490800035PRESTIGEPROPRESTIGE AMERITECH, LTD.GAX2025-04-04
00840490800045PRESTIGEPROPRESTIGE AMERITECH, LTD.GAX2025-04-04