DeRoyal

Primary DI
30749756371347
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
SP100-01
Catalog number
SP100-01
Device description
Speculet™ Disposable Eyelid Speculum
Published
2021-07-28
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNCSpecula, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNCSpecula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30749756371347PackageGS120In Commercial Distribution
50749756371341PackageGS1780In Commercial Distribution
00749756371346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975637134730749756371347
5074975637134150749756371341
00749756371346007497563713467497563713460749756371346

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid speculum, single-useA self-retaining ophthalmic surgical instrument intended to be used to retract the eyelids during an ophthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours. 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
08175700102636Ophthalmic SpeculumAURORA SURGICAL, LLCHNC2024-01-10
08175700102643Ophthalmic SpeculumAURORA SURGICAL, LLCHNC2024-01-10
08175700102650Ophthalmic SpeculumAURORA SURGICAL, LLCHNC2024-01-10
08175700100489Ophthalmic SpeculumAURORA SURGICAL, LLCHNC2024-01-09
08175700100571Ophthalmic SpeculumAURORA SURGICAL, LLCHNC2024-01-09
08175700102605Ophthalmic SpeculumAURORA SURGICAL, LLCHNC2024-01-09
08175700102612Ophthalmic SpeculumAURORA SURGICAL, LLCHNC2024-01-09
08175700102629Ophthalmic SpeculumAURORA SURGICAL, LLCHNC2024-01-09
G346E12150Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2023-02-13
G346E1253R0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-19
G346E1254L0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-19
G346E1254R0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-19
G346E11250Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E11260Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E11440Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E11490Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E11560Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E12010Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E12020Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E12030Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E12050Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E12060Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E12070Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E12100Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E12210Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E1230Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E1253L0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E12650Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E145K0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E1460Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16