FDA.reportPublic FDA data

Wexler Surgical, Inc.

Primary DI
M944AL105710
Brand
Wexler Surgical, Inc.
Company
WEXLER SURGICAL, INC.
Model
AL1057.1
Published
2020-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXNProbe, Test, Heart-Valve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXNProbe, Test, Heart-ValveCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M944AL105710PrimaryHIBCC0
00840240907673SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840240907673008402409076738402409076730840240907673

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological probeA slender, rod-like, hand-held manual surgical instrument, typically made of flexible metal with a blunt bulbous tip, designed for exploring gastroenterological/urological (GU) structures during a GU procedure. 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
M7408606028Duo Ti Expandable Interbody Fusion SystemSPINEOLOGY INC.LXN2023-12-29
M7405210002Universal Dilator SPINEOLOGY INC.LXN2023-12-19
M7405230003Universal Dilator SPINEOLOGY INC.LXN2023-12-19
00851788001167On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.LXN2023-08-09
05415067042316NAST. JUDE MEDICAL, INC.LXN2023-05-19
15415067042313NAST. JUDE MEDICAL, INC.LXN2023-05-19
00896208000269Leaflet TesterCorcym Canada CorpLXN2021-04-20
00886333222940Bone Access NeedleARGON MEDICAL DEVICES, INC.LXN2016-09-21
20886333222944Bone Access NeedleARGON MEDICAL DEVICES, INC.LXN2016-09-21