FDA.report

DeRoyal

Primary DI
50749756026432
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
30-131
Catalog number
30-131
Device description
Absorbent 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

Related Records

Contact Domains

Product Codes

CodeName
EFNCOTTON, ROLL

Product Code Classifications

CodeDeviceSpecialtyClass
EFNCotton, RollDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50749756026432PackageGS1250In Commercial Distribution
00749756026437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975602643250749756026432
00749756026437007497560264377497560264370749756026437

GMDN Terms

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

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

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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

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10810132808200House Brand DentistryFrontier Dental Supply IncEFN2025-08-05
00840456214947JMUJMU DENTAL, INCEFN2025-07-15
00840456214954JMUJMU DENTAL, INCEFN2025-07-15
00840456214961JMUJMU DENTAL, INCEFN2025-07-15
00840456214978JMUJMU DENTAL, INCEFN2025-07-15
20810132044285HCS SourcingConcordance Healthcare Solutions LLCEFN2025-04-07
20810132044278HCSConcordance Healthcare Solutions LLCEFN2025-03-05
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00304040184806Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184813Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
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00304040184868Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
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00850053289545SURGYCOSurgyco LLCEFN2024-08-09
00304040184837Henry ScheinHENRY SCHEIN, INC.EFN2024-06-26
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20815878028483Burkhart Non-Woven SpongesCROSSTEX INTERNATIONAL, INC.EFN2024-04-09
00653078997552Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2023-12-15
00810124531225Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2023-12-15
00810124531218Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2023-12-15
D79620001MARK3CARGUS INTERNATIONAL, INCEFN2023-08-01