FDA.reportPublic FDA data

Wexler Surgical, Inc.

Primary DI
M944HL005230
Brand
Wexler Surgical, Inc.
Company
WEXLER SURGICAL, INC.
Model
HL0052.3
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
HNASpud, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNASpud, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M944HL005230PrimaryHIBCC0
00840240922188SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840240922188008402409221888402409221880840240922188

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic knife, reusableA hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ diamond blades. 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
05056111322123SurtexSURTEX INSTRUMENTS LTD.HNA2026-05-12
00041533986539Bruder KarpeckiThe Hilsinger Company Parent, LlcHNA2026-02-25
00041533996538Bruder KarpeckiThe Hilsinger Company Parent, LlcHNA2026-02-25
00194613004521MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613005344MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613005351MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613005368MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613030643MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613091859MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613121792MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613121969MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
G412PH60920MR PHACOCrestpoint Management LimitedHNA2025-06-07
G412PH60930MR PHACOCrestpoint Management LimitedHNA2025-06-07
00194613005337MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613005375MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613021139MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613039899MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613053932MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00757770408993Bausch + LombBausch & Lomb IncorporatedHNA2024-11-21
00757770414284Bausch + LombBausch & Lomb IncorporatedHNA2024-11-21
00757770418893Bausch + LombBausch & Lomb IncorporatedHNA2024-11-21
00887482108628Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HNA2024-08-20
G586OP7125400Novo SurgicalNOVO SURGICAL, INC.HNA2023-12-18
G586OP7125540Novo SurgicalNOVO SURGICAL, INC.HNA2023-12-18
00190776355371MillenniumAvalign Technologies, Inc.HNA2023-11-17
00190776355388MillenniumAvalign Technologies, Inc.HNA2023-11-17
00190776069575AvalignAvalign Technologies, Inc.HNA2023-06-23
G2231108400Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNA2023-06-08
14026704799395PILLINGTELEFLEX INCORPORATEDHNA2022-12-08
14026704799401PILLINGTELEFLEX INCORPORATEDHNA2022-12-08