FDA.reportPublic FDA data

Malosa Medical

Primary DI
35055186207848
Brand
Malosa Medical
Company
Beaver-Visitec International, Inc.
Model
MMSU1277S
Catalog number
MMSU1277S
Device description
Pointed IVT Marker 3.5/4.0mm Blue
Published
2022-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMQMarker, Sclera

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMQMarker, ScleraOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35055186207848PrimaryGS10
05055186207847Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3505518620784835055186207848
05055186207847050551862078475055186207847

GMDN Terms#

Term, Definition table
TermDefinition
Scleral marker, single-useA manual instrument intended to be used to indent or imprint the surface of the sclera during an ophthalmic surgical or perioperative procedure. It is typically a hand-held instrument or a thimble-like device (placed on the end of a finger) and is made of metal (e.g., high-grade stainless steel) or synthetic polymer materials. Various types are available, including the Gass scleral marker that creates a minuscule indentation, the Awh scleral marker that creates parallel scored lines, and the Awh horseshoe design. The device is typically used for retinal detachment surgery. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
18669068080customersupport@beaver-visitec.com

Regulatory Flags#

DUNS number
001406024
Device count
20
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
30886158015292Parasol®A14-200A14-2002022-02-01
30886158015315Parasol®A14-2022022-02-01
30886158015322PARASOL®A14-203A14-2032022-02-02
30886158015414Parasol®A14-202BN2022-02-01
30886158015421PARASOL®A14-203BNA14-203BN2022-02-02
30886158015544PARASOL®A14-203QLA14-203QL2022-02-02
30886158012550Ultracell40400-82016-09-19
30886158012604UltracellNS40400-82016-09-19
30886158012611UltracellS40400-82016-09-19
30886158012628Ultracell408102016-09-19
30886158012642Ultracell408002016-09-20
30886158012659Ultracell40405-82016-09-19
30886158013205UltraClean™408152016-09-19
30886158014714UltracellBS40400-82016-09-19
30886158016015Endo Optiks®OME20002016-09-30
30886158002254Visitec®5810195810192024-06-27
30886158002650Visitec®5817085817082024-06-06
30886158010358Visitec000860100086012024-06-06
00886158002321Visiwipe5810475810472025-09-10
00886158106586BVIELP19CU5ELP19CU52025-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770498758Bausch + LombBausch & Lomb IncorporatedHMQ2025-08-04
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00194613086541MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613086558MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
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00194613086572MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613087197MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
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00194613087524MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613099817MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613101473MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613110345MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613110659MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613111151MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613111304MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613111526MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613121372MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
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00194613123697MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00810123483662Vortex Surgical Inc.Vortex Surgical, Inc.HMQ2025-04-18
00810123483655Vortex Surgical Inc.Vortex Surgical, Inc.HMQ2025-04-18
00194613086534MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613087265MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613109660MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613111168MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613111892MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613040918MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2024-08-15
00194613040925MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2024-08-15
00194613040932MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2024-08-15