FDA.reportPublic FDA data

Visitec®

Primary DI
30886158101247
Brand
Visitec®
Company
Beaver-Visitec International, Inc.
Model
585013
Catalog number
585013
Device description
Lacrimal Intubation with Retrieval Device.60mm x 11cm (23G x 4 1/4in)3
Published
2021-11-01
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
HNLProbe, Lachrymal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNLProbe, LachrymalOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K831901000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K831901000LACIMAL INTUBATION SETSVisitec Co.1983-07-12HNL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30886158101247PrimaryGS10
00886158101246Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088615810124730886158101247
00886158101246008861581012468861581012460886158101246

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal tube insertion hook/pusherA hand-held manual instrument intended for introducing a lacrimal tube/stent into the canaliculi, nasolacrimal duct, and/or nasal cavity through the corner of the eye, during a lacrimal intubation procedure for treating pathologies of the tear drainage system. It may be in the form of a cylinder for pushing the lacrimal tube downwards into the nasal cavity [post-osteotomy during canalicular bypass surgery, dacryocystorhinostomy (DCR)], or a pigtail hook probe that is inserted into the canaliculi through one lacrimal duct punctum and rotated for retrieval via the other punctum, leaving the attached lacrimal tube to be inserted in the canaliculi. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
001406024
Device count
3
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
00198506090677ELMED INCORPORATEDELMED INCORPORATEDHNL2026-05-12
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00757770460670Bausch + LombBausch & Lomb IncorporatedHNL2026-04-29
00190776410476MillenniumAvalign Technologies, Inc.HNL2025-09-11
00757770408818Bausch + LombBausch & Lomb IncorporatedHNL2025-08-14
00194613010690MSI Precision Specialty InstrumentsMed Saver, Inc.HNL2025-08-01
00194613010706MSI Precision Specialty InstrumentsMed Saver, Inc.HNL2025-08-01
00194613111731MSI Precision Specialty InstrumentsMed Saver, Inc.HNL2025-08-01
04058935011819Bowman lachrymal probe, 0000-000Bausch & Lomb GmbHHNL2025-07-11
00840343726478GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726485GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726492GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726508GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726515GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726522GEN2SURGIX MEDICAL LLCHNL2025-06-16
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G412PH19600MR PHACOCrestpoint Management LimitedHNL2025-06-07
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G412PH19840MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19850MR PHACOCrestpoint Management LimitedHNL2025-06-07