FDA.reportPublic FDA data

Malosa Medical

Primary DI
05055186204624
Brand
Malosa Medical
Company
Beaver-Visitec International, Inc.
Model
MMSU1102S
Catalog number
MMSU1102S
Device description
Govan Manipulator
Published
2022-02-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNQHook, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35055186204625PrimaryGS10
05055186204624Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3505518620462535055186204625
05055186204624050551862046245055186204624

GMDN Terms#

Term, Definition table
TermDefinition
Ocular hook/spatula/manipulator, single-useA hand-held, blunt, manual ophthalmic surgical instrument intended for manipulation/retraction of intraocular structures, lens nucleus splitting/manipulation, removal of foreign bodies in the eye, corneal manipulation (e.g., LASIK flap lifting), and/or in situ intraocular lens (IOL) manipulation/implantation; it is neither intended to cut tissue nor hook muscles. It may be of single- or double-ended design with a working end(s) designed as a hook, spatula, or other manipulator (often Y-shaped); it is not a curette, loop, trabeculotome, spoon, or inner limiting membrane (ILM) scraper. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18669068080customersupport@bvimedical.com

Regulatory Flags#

DUNS number
001406024
Device count
20
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886158106609BVIOME6000UOME6000U2025-08-11
00886158034247BVIFS6000FS60002025-07-22
00886158034674BVIELP19SU1ELP19SU12025-07-22
00886158034681BVIELP19CU1ELP19CU12025-07-22
00886158037569BVIFS6001FS60012025-07-22
00886158037576BVIOME6001UOME60012025-07-22
30886158032121CustomEyes®58001721580017212024-07-01
30886158032428CustomEyes®58001713580017132024-07-01
30886158032435CustomEyes®58001764580017642024-07-01
30886158032442CustomEyes®58001711580017112024-07-01
30886158032473CustomEyes®58001706580017062024-07-01
30886158032480CustomEyes®58001737580017372024-07-01
30886158032497CustomEyes®58001753580017532024-07-01
30886158032787CustomEyes®58001809580018092024-07-01
30886158032800CustomEyes®58001775580017752024-07-01
30886158032886CustomEyes®58001774580017742024-07-01
30886158032893CustomEyes®58001825580018252024-07-01
30886158032985CustomEyes®58001836580018362024-07-01
30886158033166CustomEyes®58001865580018652024-07-01
30886158033180CustomEyes®58001818580018182024-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417581MillenniumAvalign Technologies, Inc.HNQ2026-03-04
00810123209828Adler Instrument CompanyAdler, Inc.HNQ2026-02-10
00190776415662MillenniumAvalign Technologies, Inc.HNQ2026-02-02
00840319758663Hayden MedicalHayden Medical, Inc.HNQ2026-01-30
00190776415211MillenniumAvalign Technologies, Inc.HNQ2026-01-27
00840319758557Hayden MedicalHayden Medical, Inc.HNQ2025-12-31
G2231394680Sinskey lens manipulating hookMedetz Surgical Instruments LLCHNQ2025-12-16
00852194002076HAI HookHightech American Industrial Labs IncHNQ2025-12-15
09348811119902INKAThe Trustee for KAISER FAMILY TRUSTHNQ2025-12-03
00757770636228Bausch + LombBausch & Lomb IncorporatedHNQ2025-11-14
00757770645732Bausch + LombBausch & Lomb IncorporatedHNQ2025-09-12
00757770683666Bausch + LombBausch & Lomb IncorporatedHNQ2025-09-12
00840319758250Hayden MedicalHayden Medical, Inc.HNQ2025-09-12
00840319758229Hayden MedicalHayden Medical, Inc.HNQ2025-08-29
00757770421701Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-22
00757770636884Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-14
00757770673964Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-14
G22312244990Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2025-08-11
G2231458300Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2025-08-11
G223997034050Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2025-08-11
00757770478613Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00757770507481Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00757770510962Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00757770535514Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00757770535682Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00194613004224MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01
00194613004446MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01
00194613004453MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01
00194613004583MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01
00194613004590MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01