FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756981847
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
89-9886
Catalog number
89-9886
Device description
TONSIL PACK
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
OGREar, nose, and throat surgical tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGREar, Nose, And Throat Surgical TrayEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756981847PackageGS15In Commercial Distribution
00749756981842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975698184750749756981847
00749756981842007497569818427497569818420749756981842

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, single-useA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. 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
true
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
00749756401944DeRoyal46-LT5S-0546-LT5S-052026-05-14
00749756998857DeRoyal99-021399-02132019-11-09
00749756998864DeRoyal99-021499-02142019-11-09
00749756998871DeRoyal99-021599-02152019-11-09
00749756998888DeRoyal99-021699-02162019-11-09
00749756998901DeRoyal99-021799-02172019-11-09
00749756998918DeRoyal99-021899-02182019-11-09
00749756998925DeRoyal99-021999-02192019-11-09
00749756998956DeRoyal99-022099-02202019-11-09
00749756998963DeRoyal99-022199-02212019-11-09
00749756998970DeRoyal99-022299-02222019-11-09
00749756998642DeRoyal99-021199-02112021-05-07
00749756401685DeRoyalNP-7DAYKITUTSNP-7DAYKITUTS2026-04-02
00749756401951DeRoyal46-LT20S-0446-LT20S-042026-04-02
00749756401968DeRoyal46-LT19S-0446-LT19S-042026-04-02
00749756402033DeRoyal46-LB5546-LB552026-04-02
00749756879699DeRoyal1104SPP1104SPP2026-04-02
00749756879705DeRoyal1104MPP1104MPP2026-04-02
00749756879712DeRoyal1104LPP1104LPP2026-04-02
00749756879729DeRoyal1104XLPP1104XLPP2026-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196884704Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2025-01-19
10193489212303Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2023-06-08
10193489212877Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2023-06-08
H65857031985Henry ScheinHENRY SCHEIN, INC.OGR2022-09-19
10193489063912Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-19
10193489287547Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489288261Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489290424Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489290691Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489290783Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489290912Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489292008Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489292015Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489292497Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489292503Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489292596Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489293371Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489293401Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489294118Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489294682Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489294699Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489294767Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489295856Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489295894Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489296907Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489297287Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489299120Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489299977Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489300598Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09
10193489301564Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGR2021-11-09