FDA.report

Malosa Medical

Primary DI
05055186207809
Brand
Malosa Medical
Company
Beaver-Visitec International, Inc.
Model
MMSU1275S
Catalog number
MMSU1275S
Device description
Barraquer Speculum Flat Blade
Published
2022-02-19
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

Related Records

Contact Domains

Product Codes

CodeName
HNCSpecula, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNCSpecula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
35055186207800PrimaryGS10
05055186207809Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3505518620780035055186207800
05055186207809050551862078095055186207809

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
18669068080customersupport@beaver-visitec.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
true
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 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

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