FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756938490
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
89-9233
Catalog number
89-9233
Device description
BASIC EYE PACK
Published
2021-05-07
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
OJKEye tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJKEye TrayOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756938490PackageGS120In Commercial Distribution
00749756938495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975693849050749756938490
00749756938495007497569384957497569384950749756938495

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery 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
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
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
10193489212310Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489217391Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489413038Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489417180Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489419375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489419382Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489421590Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489422702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489424133Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489426007Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489427400Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489427950Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489428308Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489428384Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489429015Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489430707Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489438161Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489441918Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489442588Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489443028Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489444117Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489445770Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489445930Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489449112Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489449129Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489449471Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489453256Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489453485Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489455670Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489457209Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08