FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756032068
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
31-587
Catalog number
31-587
Device description
Cotton Balls
Published
2021-06-30
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
FRLFIBER, MEDICAL, ABSORBENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756032068PackageGS150In Commercial Distribution
00749756032063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975603206850749756032068
00749756032063007497560320637497560320630749756032063

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical spongeA non-medicated cushion-like mass made of absorbent materials (e.g., woven gauze, cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge or cottonoid pad/pattie, it may also be used for prepping the patient. It does not contain special features to help detect gossypiboma (sponge left inside patient) [i.e., it is not radiopaque]. 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
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 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
B090MT630MorTan ZIEN MEDICAL TECHNOLOGIES, INC.FRL2026-02-17
26931918139798AllesetGRI Medical & Electronic Technology Co., Ltd.FRL2026-02-09
06947052762262ourmedShandong Hengfa Hygienic Products Co., Ltd.FRL2025-12-30
00850067106012Austin Medical, IncAUSTIN MEDICALFRL2025-12-22
00850067106050Austin Medical, IncAUSTIN MEDICALFRL2025-12-22
00850067106067Austin Medical, IncAUSTIN MEDICALFRL2025-12-22
00859410006375SalimetricsSALIMETRICS, LLCFRL2025-12-10
26931918102051HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
26931918103966HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
26931918107933HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
10858303003009Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.FRL2025-09-25
10858303003016Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.FRL2025-09-25
10858303003030Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.FRL2025-09-25
10858303003047Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.FRL2025-09-25
26931918100910HALYARDGRI Medical & Electronic Technology Co., Ltd.FRL2025-09-17
26931918146857AllesetGRI Medical & Electronic Technology Co., Ltd.FRL2025-06-20
30888277653614MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-06-02
20613647027572FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.FRL2025-04-30
20613647027589FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.FRL2025-04-30
20613647027596FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.FRL2025-04-30
20613647027602FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.FRL2025-04-30
30193489003592MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-04-25
50197106935130CARDINAL HEALTHCardinal Health 200, LLCFRL2025-02-24
20810178830132Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
20810178830149Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
20810178830156Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
20810178830163Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
20810178830170Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
20810178830187Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
E2212248Sticky TimVOCO GmbHFRL2025-01-22