FDA.reportPublic FDA data

Wexler Surgical, Inc.

Primary DI
M944BL001040
Brand
Wexler Surgical, Inc.
Company
WEXLER SURGICAL, INC.
Model
BL0010.4
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
OHWBurr, Corneal, Battery Powered, Rust Ring Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHWBurr, Corneal, Battery Powered, Rust Ring RemovalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M944BL001040PrimaryHIBCC0
00840240911359SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840240911359008402409113598402409113590840240911359

GMDN Terms#

Term, Definition table
TermDefinition
Corneal bur handpiece, battery-poweredA battery-powered, hand-held rotating device designed to perform corneal, and other ophthalmic tissue, abrasion through a bur attached to its distal tip. The device typically stops if the pressure on the tissue (e.g., cornea) is beyond a pre-established limit. It is used (with appropriate burs) to clean rust rings from the cornea after the extraction of a ferrous foreign object, to polish corneal scratches and/or the pterygium bed after surgical removal, and/or for abrasion of lid margin lesions. 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
00194613005184MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005191MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005207MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005221MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005245MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005252MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005276MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005283MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005290MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005306MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005313MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005320MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613020002MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613021122MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613036492MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613036508MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613102432MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613122089MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613122478MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-08-01
00194613005214MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-03-21
00194613005238MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-03-21
00194613005269MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-03-21
00194613020019MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-03-21
00194613021115MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-03-21
00194613109189MSI Precision Specialty InstrumentsMed Saver, Inc.OHW2025-03-21
00841668132623ALGERBRUSH CORN RUST RING REM 0.5MM BURRKATENA PRODUCTS, INC.OHW2022-12-07
00841668132630ALGERBRUSH RUST RING REM BURR 0.5MMKATENA PRODUCTS, INC.OHW2022-12-07
00841668132647ALGERBRUSH CORN RUST RING REM BURR 1.0MMKATENA PRODUCTS, INC.OHW2022-12-07
00841668132654YOSHIDA DIAMOND COATED BURRKATENA PRODUCTS, INC.OHW2022-12-07
00841668132661ALGERBRUSH RUST RING REM CHUCK .5MM BURRKATENA PRODUCTS, INC.OHW2022-12-07