FDA.reportPublic FDA data

MORIA

Primary DI
03700483608829
Brand
MORIA
Company
MORIA SA
Model
Micro Beehler Pupil Dilator, curved
Catalog number
19009/2.8
Published
2023-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HNIRetractor, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNIRetractor, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700483608829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700483608829037004836088293700483608829

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical spatulaA hand-held manual surgical instrument designed to manipulate tissue during various types of surgical interventions. It typically consists of a flat blunt blade (no sharp edges) that is double-ended (a blade at either end) and is not constructed for one particular part of the anatomy or clinical specialty. It is usually made of high-grade stainless steel and is available with a variety of blade designs, e.g., curved and flat or straight and flat with rounded ends; some blade types may be more right-angled. The handle will be formed from its middle section and may be more prominent/serrated. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
275937506
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
03700483602124MORIACBSU 300 HEAD - ART. CHAMBER19178/3002024-05-07
03700483603107MORIACBSU 350 HEAD - ART. CHAMBER19178/3502024-05-07

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Primary DI, Brand, Company table
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00190776420840MillenniumAvalign Technologies, Inc.HNI2026-04-30
00190776420512MillenniumAvalign Technologies, Inc.HNI2026-04-16
G22351091I0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNI2026-04-09
00190776418007MillenniumAvalign Technologies, Inc.HNI2026-03-23
00757770668427Bausch + LombBausch & Lomb IncorporatedHNI2026-02-04
00757770708260Bausch + LombBausch & Lomb IncorporatedHNI2026-02-04
00757770652518Bausch + LombBausch & Lomb IncorporatedHNI2025-09-12
00757770668083Bausch + LombBausch & Lomb IncorporatedHNI2025-09-12
G2231109830Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNI2025-08-11
00757770421985Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770423934Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770455720Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770510405Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770437429Bausch + LombBausch & Lomb IncorporatedHNI2025-08-05
00757770668519Bausch + LombBausch & Lomb IncorporatedHNI2025-08-05
00194613005924MSI Precision Specialty InstrumentsMed Saver, Inc.HNI2025-08-01
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00194613104177MSI Precision Specialty InstrumentsMed Saver, Inc.HNI2025-08-01
04058935011826Berke-Jaeger Lid PlateBausch & Lomb GmbHHNI2025-07-11
00850003089355N/AOptalmed, LLCHNI2025-07-07
00850003089362N/AOptalmed, LLCHNI2025-07-07
G346EC1150Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNI2025-06-26
00190776401276MillenniumAvalign Technologies, Inc.HNI2025-06-10
G412H17300MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412H17350MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412PH62010MR PHACOCrestpoint Management LimitedHNI2025-06-07