FDA.reportPublic FDA data

Wexler Surgical, Inc.

Primary DI
M944AL130010
Brand
Wexler Surgical, Inc.
Company
WEXLER SURGICAL, INC.
Model
AL1300.1
Published
2018-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BWBForceps, Tube Introduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWBForceps, Tube IntroductionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M944AL130010PrimaryHIBCC0
00840240900971SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840240900971008402409009718402409009710840240900971

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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
05010058079922InstrapacROBINSON HEALTHCARE LIMITEDBWB2025-06-19
05010058179929InstrapacROBINSON HEALTHCARE LIMITEDBWB2025-06-19
05010058079939InstrapacROBINSON HEALTHCARE LIMITEDBWB2025-05-21
05010058179936InstrapacROBINSON HEALTHCARE LIMITEDBWB2025-05-21
00888515023420BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.BWB2024-02-28
00888515023437BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.BWB2024-02-28
00888515023451BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.BWB2024-02-28
20653160369803CenturionCENTURION MEDICAL PRODUCTS CORPORATIONBWB2023-12-28
10653160369806CenturionCENTURION MEDICAL PRODUCTS CORPORATIONBWB2023-12-28
G58678TIF020Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
G58678TIF030Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
G58678TIF040Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
G586E95686120Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
G586E95692280Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
G586E95693270Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
G586E95693280Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
07898506813551QuinelatoSchobell Industrial LtdaBWB2023-07-07
07898506849307QuinelatoSchobell Industrial LtdaBWB2023-07-07
00190776055943AvalignAvalign Technologies, Inc.BWB2023-06-23
05055382848769Eco MagillTIMESCO HEALTHCARE LIMITEDBWB2023-06-20
05055382848783Eco MagillTIMESCO HEALTHCARE LIMITEDBWB2023-06-20
05055382848806Eco MagillTIMESCO HEALTHCARE LIMITEDBWB2023-06-20
00840183504052BR Surgical, LLCBR Surgical, LLCBWB2023-04-06
00840183505042BR Surgical, LLCBR Surgical, LLCBWB2023-04-06
00840183505189BR Surgical, LLCBR Surgical, LLCBWB2023-04-06
00840183511715BR Surgical, LLCBR Surgical, LLCBWB2023-03-28
00840183519216BR Surgical, LLCBR Surgical, LLCBWB2023-03-28
07898506813568QuinelatoSchobell Industrial LtdaBWB2022-12-08
00842331185793Novo Surgical Inc. NOVO SURGICAL, INC.BWB2022-11-14
00842331167072Novo Surgical Inc. NOVO SURGICAL, INC.BWB2022-11-13