FDA.reportPublic FDA data

Wexler Surgical, Inc.

Primary DI
M944AL010410
Brand
Wexler Surgical, Inc.
Company
WEXLER SURGICAL, INC.
Model
AL0104.1
Published
2018-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNWDilator, Lachrymal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNWDilator, LachrymalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M944AL010410PrimaryHIBCC0
00840240906232SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840240906232008402409062328402409062320840240906232

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal probe, reusableA hand-held, manual, slender rod-like ophthalmic surgical instrument made of flexible metal, with a blunt bulbous tip, used for exploring the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
024882552
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M944VL040020Wexler Surgical, Inc.VL0400.22018-09-23
M944NL8606150Wexler Surgical, Inc.NL8606.152025-12-26
M944SHARB60Wexler Surgical, Inc.SHA-RB62025-10-10
M944SACRB3L0Wexler Surgical, Inc.SA-C-RB3L2025-08-22
M944SACRB4L0Wexler Surgical, Inc.SA-C-RB4L2025-08-22
M944SACRB50Wexler Surgical, Inc.SA-C-RB52025-08-22
M944SACRB60Wexler Surgical, Inc.SA-C-RB62025-08-22
00840240938202Wexler Surgical, Inc.SA-C-RB3L2025-08-22
00840240938219Wexler Surgical, Inc.SA-C-RB4L2025-08-22
00840240938226Wexler Surgical, Inc.SA-C-RB52025-08-22
M944SARB30Wexler Surgical, Inc.SA-RB32025-05-16
M944SARB40Wexler Surgical, Inc.SA-RB42025-05-16
M944SARB50Wexler Surgical, Inc.SA-RB52025-05-16
M944SARB60Wexler Surgical, Inc.SA-RB62025-05-16
M944SARB70Wexler Surgical, Inc.SA-RB72025-05-16
00840240938127Wexler Surgical, Inc.SA-RB32025-05-16
00840240938110Wexler Surgical, Inc.SA-RB42025-05-16
00840240938103Wexler Surgical, Inc.SA-RB52025-05-16
00840240938097Wexler Surgical, Inc.SA-RB62025-05-16
M944LAFM30Wexler Surgical, Inc.LA-FM32025-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810158214538PRINCETONPrinceton Medical Group, Inc.HNW2026-04-21
00840319758892Hayden MedicalHayden Medical, Inc.HNW2026-03-31
00041533986560Bruder KarpeckiThe Hilsinger Company Parent, LlcHNW2025-11-21
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
G412PH60850MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH6085T0MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60860MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60870MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60880MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60890MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60900MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60910MR PHACOCrestpoint Management LimitedHNW2025-05-27
00810158215191PRINCETONPrinceton Medical Group, Inc.HNW2025-05-27
00810158215207PRINCETONPrinceton Medical Group, Inc.HNW2025-05-27
00810158215214PRINCETONPrinceton Medical Group, Inc.HNW2025-05-27
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