FDA.reportPublic FDA data

Wexler Surgical, Inc.

Primary DI
M944VL040020
Brand
Wexler Surgical, Inc.
Company
WEXLER SURGICAL, INC.
Model
VL0400.2
Published
2018-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNRForceps, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M944VL040020PrimaryHIBCC0
00840240936383SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840240936383008402409363838402409363830840240936383

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical instrument handle, manualA hand-held manual device designed to hold and operate a compatible ophthalmic surgical instrument tip (typically scissors, forceps). It is typically in the form of a conventional handle with a connector that secures the inserted tip, and has a manually-operated internal actuating piston that operates the inserted tip (e.g., opens and closes blades). It is typically used for surgery in the anterior or the posterior segment to cut, grasp, and manipulate eye tissue; it is not a handle for a corneal trephine. 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
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
M944LAFM3U0Wexler Surgical, Inc.LA-FM3U2025-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776411480MillenniumAvalign Technologies, Inc.HNR2026-08-07
00860013297954Ziplyft Upper Eyelid Lift KitOsheru, L.L.C.HNR2026-08-07
B382SD9028531640Surgical DirectSurgical Direct, Inc.HNR2026-08-07
G22312552000Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-08-03
00840319759202Hayden MedicalHayden Medical, Inc.HNR2026-07-30
G2231114060Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G2231119000Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G223111901T0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G22312408910Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
00190776405854MillenniumAvalign Technologies, Inc.HNR2026-07-26
00190776405878MillenniumAvalign Technologies, Inc.HNR2026-07-26
00190776398675MillenniumAvalign Technologies, Inc.HNR2026-07-21
00190776403690MillenniumAvalign Technologies, Inc.HNR2026-07-21
00190776403737MillenniumAvalign Technologies, Inc.HNR2026-07-21
00190776398668MillenniumAvalign Technologies, Inc.HNR2026-07-16
00190776398699MillenniumAvalign Technologies, Inc.HNR2026-07-16
00860015282002Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282019Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282026Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282033Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282071Intrace USAPILOTIS TECH LLCHNR2026-07-03
00840285320789Walcott Rx ProductsWalcott Rx Product IncHNR2026-06-05
G006D50190300Tuebingen Model Tying forceps strDAUD JEE MFG. COHNR2023-01-05
G006D50190400Tuebingen Model Tying forceps cvdDAUD JEE MFG. COHNR2023-01-05
G006D35072330AKAHOSHI SUPER COMBO III PRECHOPPERDAUD JEE MFG. COHNR2022-12-19
G006D50171630CORYDON FORCEPS EROGONOMIC ROUND HANDLEDAUD JEE MFG. COHNR2022-12-17
G006D5011895010COLIBRI FORCEP 0.12 W/TYING PLATFORMDAUD JEE MFG. COHNR2022-12-13
G006D5011895020COLIBRI FORCEP 0.4 W/TYING PLATFORMDAUD JEE MFG. COHNR2022-12-13
G006D5019300STORZ CASTROVEIJO COLIBRI FORCEPS 0.12DAUD JEE MFG. COHNR2022-12-13
G006D5011895030COLIBRI FORCEP 0.12 W/TYING PLATFORM OBLIQUEDAUD JEE MFG. COHNR2022-12-10