FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756049233
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
71-1122
Catalog number
71-1122
Device description
Collection Sock, Orthopedic
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
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NNICONTAINER, SPECIMEN, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756049233PackageGS120In Commercial Distribution
00749756049238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975604923350749756049233
00749756049238007497560492387497560492380749756049238

GMDN Terms#

Term, Definition table
TermDefinition
Suction system canister linerA device made of disposable materials used to cover the inner surface of a suction system reusable canister, for the collection of substances such as blood, bodily fluids, rinsing fluids, body tissue, or gas (e.g., laser plume evacuation) from a site of operation. The device may be soft-walled, or it may have walls of semi-rigid plastic with a dedicated lid. Together with the canister, it can be used singularly, or in a connected series to provide greater capacity. This device should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill). 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
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00840117337367LabChoice Pet Cell Bottle, 250 mL Dynarex CorporationNNI2025-06-16
00840117337374LabChoice Pet Cell Bottle, 500 mL Dynarex CorporationNNI2025-06-16
00840117337381LabChoice Pet Cell Bottle, 1000 mL Dynarex CorporationNNI2025-06-16
00840165500218HistoplexStarplex Scientific Corp.NNI2025-05-30
00840165500096StarCLICK 100Starplex Scientific Corp.NNI2025-05-28
00840165500119LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500133LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500157LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500171LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500195HistoplexStarplex Scientific Corp.NNI2025-05-28
00840165500416LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500430LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165401195LeakbusterPretium Canada Packaging ULCNNI2025-04-29
00840165401416LeakbusterPretium Canada Packaging ULCNNI2025-04-29
00840117336414LabChoice 24-Hour Urine Collection Container, 3000 mL Dynarex CorporationNNI2025-04-17
10827989003214Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2025-04-15
00810180841689LabChoice Specimen Bags, Clear, 8" x 10", 1.8 MILDynarex CorporationNNI2025-04-07
00810180841672LabChoice Specimen Bags with Pouch, 4" x 6", 1.8 MIL Dynarex CorporationNNI2025-04-07
29120126131459VACUETTEGreiner Bio-One GmbHNNI2025-04-02
00810180841665LabChoice Specimen Bags, 6" x 9", 1.8 MIL, Non-SterileDynarex CorporationNNI2025-03-28
00810180841658LabChoice Specimen Bags, 12" x 15", 1.8 milDynarex CorporationNNI2025-03-28
10827989003221Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2025-03-13
00810180841467LabChoice Specimen Containers, 60 mL, Non-SterileDynarex CorporationNNI2025-03-11
00810180841474LabChoice Specimen Containers, 100 mL, NonSterileDynarex CorporationNNI2025-03-11
00810180841450LabChoice Specimen Containers, 40 mL, Non-SterileDynarex CorporationNNI2025-03-11
00860009784895Ditek Urine Collection CupMedzah IndustriesNNI2025-03-06
00840165400976Starplex Pretium Canada Packaging ULCNNI2025-03-04
00850025860017ESD Specimen TrayMicro-tech UsaNNI2025-02-28
04250306301219SalivaGene CollectorInvitek Molecular GmbHNNI2025-02-12