DeRoyal

Primary DI
00749756371346
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
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
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.

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
00749756402316DeRoyalNP-6006ULNP-6006UL2026-10-16
00749756402323DeRoyalNP-6007ULNP-6007UL2026-10-16
00749756402330DeRoyalNP-6008ULNP-6008UL2026-10-16
00749756402347DeRoyalNP-0080ULNP-0080UL2026-10-16
00749756402354DeRoyalNP-6014ULNP-6014UL2026-10-16
00749756402361DeRoyalNP-6015ULNP-6015UL2026-10-16
00749756402378DeRoyalNP-6016ULNP-6016UL2026-10-16
00749756402989DeRoyalNP-0250UNP-0250U2026-09-30
00749756402996DeRoyalNP-0450UNP-0450U2026-09-30
00749756403009DeRoyalNP-0450UNNP-0450UN2026-09-30
00749756403016DeRoyalNP-0250UNNP-0250UN2026-09-30
00749756403023DeRoyalNP-0250U-01NP-0250U-012026-09-30
00749756403375DeRoyal31-120P31-120P2026-09-30
00749756369640DeRoyalNP-7000NP-70002026-09-23
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

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