FDA.reportPublic FDA data

Visitec®

Primary DI
00886158101239
Brand
Visitec®
Company
Beaver-Visitec International, Inc.
Model
585012
Catalog number
585012
Device description
DCR Set (Angled) [O'Donoghue] .90mm x 4.5cm (20G x 1 3/4in)
Published
2021-11-01
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
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
30886158101230PrimaryGS10
00886158101239Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088615810123030886158101230
00886158101239008861581012398861581012390886158101239

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal intubation setA collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
001406024
Device count
3
DM exempt
false
Premarket exempt
false
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
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
20757770455953Bausch + LombBausch & Lomb IncorporatedHNL2026-04-29
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
G412PH19980MR PHACOCrestpoint Management LimitedHNL2025-06-09
G412PH19600MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19750MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197500MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH1975000MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197510MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197520MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197530MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197540MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19800MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19810MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19820MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19830MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19840MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19850MR PHACOCrestpoint Management LimitedHNL2025-06-07