FDA.reportPublic FDA data

ONE

Primary DI
03700483611911
Brand
ONE
Company
MORIA SA
Model
One S-adj speculum with swivels x5
Catalog number
17508X5
Published
2023-12-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
03700483620449PackageGS15In Commercial Distribution
03700483611911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700483620449037004836204493700483620449
03700483611911037004836119113700483611911

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.

Regulatory Flags#

DUNS number
275937506
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700483630219MORIADUAL ACTION SINSKEY MANIPULATOR200672026-09-25
03700483630240MORIADUAL ACTION CURVED SCRAPER200682026-09-25
00370048360849MORIAEPI-K REUSABLE SUCTION RING 019389/02026-07-20
03700483600397MORIAM2SU 130 HEAD19334/1302026-07-20
03700483600410MORIAM2SU 90 HEAD19334/902026-07-20
03700483600557MORIAEPI-K SET (-1 RING)193842026-07-20
03700483600571MORIAEpi-K Head193902026-07-20
03700483608416MORIAEPI-K HANDPIECE193422026-07-20
03700483608485MORIAEPI-K REUSABLE SUCTION RING -119389/-12026-07-20
03700483608553MORIAEPI-K LD REUSABLE SUCTION RING -119399/-12026-07-20
03700483628179MORIARADIAL MARKER 8 BLADES20148/82026-07-16
03700483628209MORIARADIAL MARKER 16 BLADES20148/162026-07-16
03700483628261MORIARADIAL MARKER 12 BLADES20148/122026-07-16
03700483600243MORIAEvolution 2-3-3E tubing x10191382023-12-27
03700483630479MORIAGoosey Forceps190902026-04-21
03700483603206MORIAOU LC 250 HEAD ARTIFICIAL CHAMBER19184/2502024-05-07
03700483601974MORIACBSU 50 HEAD - ART. CHAMBER19178/502024-05-07
03700483602032MORIACBSU 130 HEAD - ART. CHAMBER19178/1302024-05-07
03700483602094MORIACBSU 110 HEAD - ART. CHAMBER19178/1102024-05-07
03700483602100MORIACBSU 250 HEAD - ART. CHAMBER19178/2502024-05-07

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