DeRoyal

Primary DI
00749756371353
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
SP100-02
Catalog number
SP100-02
Device description
Speculet Disposable Eyelid Speculum
Published
2021-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

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
30749756371354PackageGS120In Commercial Distribution
50749756371358PackageGS1780In Commercial Distribution
00749756371353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975637135430749756371354
5074975637135850749756371358
00749756371353007497563713537497563713530749756371353

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.

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
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756389181DeRoyal81-1020SU81-1020SU2026-09-21
00749756389204DeRoyal81-1020REF81-1020REF2026-09-21
00749756399258DeRoyal46-326XBNS46-326XBNS2026-09-21
00749756400442DeRoyal77-40111877-4011182026-09-21
00749756985475DeRoyalNP-790NP-7902026-09-21
00749756985963DeRoyalNP-7300-01NP-7300-012026-09-21
00749756985994DeRoyalNP-7300NP-73002026-09-21
00749756986250DeRoyalNP-7300NNP-7300N2026-09-21
00749756394666DeRoyal47-820KG47-820KG2026-09-18
00749756397193DeRoyal47-813KG-0147-813KG-012026-09-18
00749756397339DeRoyal15410002154100022026-09-18
00749756397346DeRoyal15410003154100032026-09-18
00749756400800DeRoyal32-219532-21952026-09-18
00749756401289DeRoyalNP-7000-GPSNP-7000-GPS2026-09-18
00749756401678DeRoyal13-809A-01-COSM13-809A-01-COSM2026-09-18
00749756401692DeRoyalNP-6007U-01NP-6007U-012026-09-18
00749756401708DeRoyal46-LB19546-LB1952026-09-18
00749756401715DeRoyal46-LB38546-LB3852026-09-18
00749756401739DeRoyalM60-SF510TM60-SF510T2026-09-18
00749756401746DeRoyalNP-120UNP-120U2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776424046MillenniumAvalign Technologies, Inc.HNC2026-08-27
00190776407452MillenniumAvalign Technologies, Inc.HNC2026-07-31
G22312042490Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNC2026-07-27
00190776397074MillenniumAvalign Technologies, Inc.HNC2026-07-16
00190776398682MillenniumAvalign Technologies, Inc.HNC2026-07-16
00190776396770MillenniumAvalign Technologies, Inc.HNC2026-07-14
G346E12710Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2026-06-23
00757770668540Bausch + LombBausch & Lomb IncorporatedHNC2026-06-22
00198506091513ELMED INCORPORATEDELMED INCORPORATEDHNC2026-06-10
00198506091520ELMED INCORPORATEDELMED INCORPORATEDHNC2026-06-10
04251047900174Kratz-Barraquer Wire SpeculumA1 Medical GmbHHNC2026-05-29
04251047900655Lieberman Eye SpeculumA1 Medical GmbHHNC2026-05-29
04251047900679Lieberman Eye SpeculumA1 Medical GmbHHNC2026-05-29
04251047900686Lieberman Eye SpeculumA1 Medical GmbHHNC2026-05-29
04251047932373Mod. Krumeich Eye SpeculumA1 Medical GmbHHNC2026-05-29
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