FDA.reportPublic FDA data

Wexler Surgical, Inc.

Primary DI
M944SARB50
Brand
Wexler Surgical, Inc.
Company
WEXLER SURGICAL, INC.
Model
SA-RB5
Published
2025-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EQJBur, Ear, Nose And Throat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQJBur, Ear, Nose And ThroatEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M944SARB50PrimaryHIBCC0
00840240938103SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840240938103008402409381038402409381030840240938103

GMDN Terms#

Term, Definition table
TermDefinition
Diamond ENT bur, single-useA rotary cutting device made of a high-grade steel shank with the working end coated with particles of diamond, and which is designed to fit into a powered handpiece that provides the rotation for incising or removing bone in the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device.

Regulatory Flags#

DUNS number
024882552
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
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
08904461028783OSSEOUS- Shaver Blade Tube EON MEDITECH PRIVATE LIMITEDEQJ2026-03-13
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAEQJ2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAEQJ2025-03-21
07630055508072PM2-S MISBien-Air Surgery SAEQJ2025-03-21
07630055508065PM2-A MISBien-Air Surgery SAEQJ2025-03-20
07613327576801PELLOSTRYKER CORPORATIONEQJ2024-11-13
07613327576825PELLOSTRYKER CORPORATIONEQJ2024-11-13
08904428723409OSSEOUS Blade - Inferior turbinate - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723416OSSEOUS Blade - Inferior turbinate - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723423OSSEOUS Blade-Straight Sinus Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723430OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723447OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723454OSSEOUS Blade-Curved Sinus Blades - TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723461OSSEOUS Blade-Curved Sinus Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723478OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723485OSSEOUS Blade-Curved Sinus Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723492OSSEOUS Blade-Curved Sinus Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723515OSSEOUS Blade - Inferior turbinate - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723539OSSEOUS Blade-Straight Sinus Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723546OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723553OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723560OSSEOUS Blade-Curved Sinus Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904428723577OSSEOUS Blade-Curved Sinus Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904461000505OSSEOUS Blade-Curved Sinus Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904461000529OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - M TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904461001571OSSEOUS Blades-Straight Sinus Blades - N TypeEON MEDITECH PRIVATE LIMITEDEQJ2024-07-10
08904461000956OSSEOUS Burs-Course DiamondEON MEDITECH PRIVATE LIMITEDEQJ2024-07-05
08904461000888OSSEOUS Burs-Tungsten CarbideEON MEDITECH PRIVATE LIMITEDEQJ2024-07-04
08904461000895OSSEOUS Burs-Tungsten CarbideEON MEDITECH PRIVATE LIMITEDEQJ2024-07-04
08904461000901OSSEOUS Burs-Tungsten CarbideEON MEDITECH PRIVATE LIMITEDEQJ2024-07-04