FDA.reportPublic FDA data

Wexler Surgical, Inc.

Primary DI
M944HL003210
Brand
Wexler Surgical, Inc.
Company
WEXLER SURGICAL, INC.
Model
HL0032.1
Published
2018-03-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNQHook, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M944HL003210PrimaryHIBCC0
00840240922089SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840240922089008402409220898402409220890840240922089

GMDN Terms#

Term, Definition table
TermDefinition
Lens loop, reusableA hand-held, manual, ophthalmic surgical instrument designed for eye lens extraction and gentle manipulation and/or irrigation of eye tissues during an ophthalmic surgical procedure. It typically consists of a small wire loop (frequently serrated) at the distal tip and a handle for easy manipulation; it may also include a channel (e.g., a cannula) which is connected to an external irrigator for irrigation of the eye. 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
04251047925849Vera Fixation HookA1 Medical GmbHHNQ2026-05-29
00190776421151MillenniumAvalign Technologies, Inc.HNQ2026-05-04
00190776420833MillenniumAvalign Technologies, Inc.HNQ2026-04-30
00757770522750Bausch + LombBausch & Lomb IncorporatedHNQ2026-04-30
00757770636082Bausch + LombBausch & Lomb IncorporatedHNQ2026-04-30
00190776420086MillenniumAvalign Technologies, Inc.HNQ2026-04-16
00190776420093MillenniumAvalign Technologies, Inc.HNQ2026-04-16
00190776419912MillenniumAvalign Technologies, Inc.HNQ2026-04-15
00190776414214MillenniumAvalign Technologies, Inc.HNQ2025-10-22
00810163790447Diamatrix Ltd.DiamatrixHNQ2025-10-21
00810163790454Diamatrix Ltd.DiamatrixHNQ2025-10-21
00190776412616MillenniumAvalign Technologies, Inc.HNQ2025-10-03
00190776412005MillenniumAvalign Technologies, Inc.HNQ2025-10-01
G2231196790Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2025-08-11
00810163790331Diamatrix Ltd.DiamatrixHNQ2025-05-27
10649111487934Sklar InstrumentsSKLAR CORPORATIONHNQ2025-01-03
G2231196710Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2023-09-19
00810123480883Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
00810123480890Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
00810123480906Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
00810123480913Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
G2231196700Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2023-01-12
14026704790675PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799579PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799661PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799678PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799685PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799692PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799708PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799715PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08