FDA.reportPublic FDA data

Visitec®

Primary DI
30886158006665
Brand
Visitec®
Company
Beaver-Visitec International, Inc.
Model
585229
Catalog number
585229
Device description
Soft Tip Cannula .50 x 33mm (25G x 1.3 in) 3mm tip
Published
2021-12-20
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMXCannula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30886158006665PrimaryGS10
00886158006664Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088615800666530886158006665
00886158006664008861580066648861580066640886158006664

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal douche, single-useA non-sterile, manual device designed to produce and direct a stream of fluid (typically water, water/vinegar solution, or antiseptic chemicals) into the vaginal cavity typically for hygienic purposes, including the removal of vaginal discharge, medicinal deposits, and anticonceptual products from the vagina. It usually consists of a squeeze bottle to contain the fluid, typically prefilled, with an attached nozzle for vaginal insertion; the fluid is ejected upon hand compression by the user. The device is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
001406024
Device count
10
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

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G22312624110Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2025-09-10
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