FDA.report

Lacrimal Probe

Primary DI
00192896103290
Brand
Lacrimal Probe
Company
SONTEC INSTRUMENTS, INC.
Model
16-2498
Device description
Rolfe Lacrimal Probe Knurled Handle Double-Ended Stainless Steel
Published
2020-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HNWDilator, lachrymal

Product Code Classifications

CodeDeviceSpecialtyClass
HNWDilator, LachrymalOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896103290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896103290001928961032901928961032900192896103290

GMDN Terms

TermDefinition
Lacrimal dilator, reusableA hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts

PhoneEmail
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags

DUNS number
040729840
Device count
1
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00192896015104REEH STITCH SCISSORS13-832513-83252018-09-12
00192896062238RYDER NEEDLE HOLDER2300-3152300-3152018-09-12
00192896105171Small Plates355-236A355-236A2020-10-05
00192896122833Intraocular Set1100-034-SET1100-034-SET2026-03-19
00192896122840Alyea-Babcock Vasectomy Clamp516-695516-6952026-03-19
00192896122857Diamond Head Grasping Forceps1273-1251273-1252026-03-19
00192896122864Velociraptor Junior Rongeur1273-171F1273-171F2026-03-19
00192896122871Spoon Curette2900-2222900-2222026-03-19
00192896122888Dissector2900-2332900-2332026-03-19
00192896122895Ball Dissector2900-2352900-2352026-03-19
00192896122901Hook Dissector2900-2372900-2372026-03-19
00192896122918Hook Dissector2900-2382900-2382026-03-19
00192896122925Spatula Dissector2900-2422900-2422026-03-19
00192896122932Spatula Dissector2900-2442900-2442026-03-19
00192896122949Deluxe Alligator Grasping Forceps1100-333D1100-333D2026-03-19
00192896122680Schroeder Vulsellum Bone Clamp1103-0641103-0642026-03-10
00192896122697Cooley Vascular Clamp2100-527C2100-527C2026-03-10
00192896122703Ochsner Dissector2700-155T2700-155T2026-03-10
00192896122710Debakey Coarctation Clamp2100-6312100-6312026-03-10
00192896122727Debakey Coarctation Clamp2100-6352100-6352026-03-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190776411619MillenniumAvalign Technologies, Inc.HNW2025-09-24
00194613010836MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613010867MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613010874MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613051501MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613083168MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00190776400873MillenniumAvalign Technologies, Inc.HNW2025-06-05
G2231132500Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNW2025-05-13
00810158215078PRINCETONPrinceton Medical Group, Inc.HNW2025-05-06
00194613010904MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-03-21
00810158214514PRINCETONPrinceton Medical Group, Inc.HNW2025-03-13
00810158214521PRINCETONPrinceton Medical Group, Inc.HNW2025-03-13
00840183529758BR Surgical, LLCBR Surgical, LLCHNW2025-02-14
00810158214194PRINCETONPrinceton Medical Group, Inc.HNW2025-01-27
00757770410668Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20
00757770414949Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20
00757770419166Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20
00757770420681Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20
00757770421060Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20
00757770425679Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20
00757770430680Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20
00757770434084Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20
G223M1132390Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNW2024-11-11
G2231132250Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNW2024-10-05
00194613045685MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2024-08-15
00190776385699MillenniumAvalign Technologies, Inc.HNW2024-05-09
00810158212053PRINCETONPrinceton Medical Group, Inc.HNW2024-04-26
00888867462021Arthrex®ARTHREX, INC.HNW2024-03-08
00888867462038Arthrex®ARTHREX, INC.HNW2024-03-08
00888867462045Arthrex®ARTHREX, INC.HNW2024-03-08