FDA.reportPublic FDA data

Wexler Surgical, Inc.

Primary DI
M944AL006510
Brand
Wexler Surgical, Inc.
Company
WEXLER SURGICAL, INC.
Model
AL0065.1
Published
2018-02-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HOBClamp, Muscle, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOBClamp, Muscle, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M944AL006510PrimaryHIBCC0
00840240905891SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840240905891008402409058918402409058910840240905891

GMDN Terms#

Term, Definition table
TermDefinition
Surgical bulldog clamp, reusableA hand-held manual surgical instrument designed to grasp, join, compress or support an organ, vessel or soft-tissue. It has a flat, pincer-like design with self-retaining jaws that open upon squeezing of the handles and close upon release; it is typically made of high-grade stainless steel. It is commonly used for vascular clamping and is not dedicated to a specific type of non-vascular surgery. 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
00757770406036Bausch + LombBausch & Lomb IncorporatedHOB2025-08-08
00757770409952Bausch + LombBausch & Lomb IncorporatedHOB2025-08-08
00757770420872Bausch + LombBausch & Lomb IncorporatedHOB2025-08-08
00757770522712Bausch + LombBausch & Lomb IncorporatedHOB2025-08-08
00194613007645MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613007652MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613018467MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613039769MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613095048MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613103705MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613104283MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613007669MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-03-21
00194613034313MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-03-21
00194613112691MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-03-21
00194613043988MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2024-08-15
00194613053826MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2024-08-15
00190776357634MillenniumAvalign Technologies, Inc.HOB2023-11-17
00190776351946MILLENNIUMAvalign Technologies, Inc.HOB2023-09-28
00190776358976MILLENNIUMAvalign Technologies, Inc.HOB2023-09-28
G2239661010Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOB2023-09-28
00841668118139Oph.ForcepsKATENA PRODUCTS, INC.HOB2022-11-16
00841668118146Oph.ForcepsKATENA PRODUCTS, INC.HOB2022-11-16
00190776076115AvalignAvalign Technologies, Inc.HOB2021-11-03
04049368069119N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069133N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069157N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069171N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069232N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069294N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069355N.A.Geuder AktiengesellschaftHOB2021-02-23