FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756030286
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
9810-01
Catalog number
9810-01
Device description
Retractor Cover
Published
2021-07-09
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
KDCINSTRUMENT, SURGICAL, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756030286PackageGS1100In Commercial Distribution
00749756030281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975603028650749756030286
00749756030281007497560302817497560302810749756030281

GMDN Terms#

Term, Definition table
TermDefinition
Clamp jaw cover, sterileA sterile device used in pairs that are placed/fitted onto the distal working end (the jaws) of surgical instruments (e.g., vascular clamps, haemostats and forceps) to provide improved atraumatic grip and even pressure distribution when clamping an artery or a vein. It is typically a long device designed as a cylindrical tube and made of radiopaque silicone materials; it is available in various sizes. It may also be known as jaw covers. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10653160391098Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDC2025-12-19
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00194613020576MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613043209MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
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00194613044633MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613045296MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613045302MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613045531MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613047153MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
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00194613054441MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054472MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054496MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
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00194613088194MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613089672MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613089757MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613089764MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613090890MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613091330MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613091774MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613093228MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01