FDA.report

Wexler Surgical, Inc.

Primary DI
M944AL103010
Brand
Wexler Surgical, Inc.
Company
WEXLER SURGICAL, INC.
Model
AL1030.1
Published
2016-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MGZValvulotome

Product Code Classifications

CodeDeviceSpecialtyClass
MGZValvulotomeCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M944AL103010PrimaryHIBCC0
00840240907567SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840240907567008402409075678402409075670840240907567

GMDN Terms

TermDefinition
ValvulotomeA hand-held manual surgical instrument designed for cutting an anatomical valve or valves in situ (e.g., to slit a heart valve or to cut the valves within a vein to allow blood flow in the opposite direction). It is typically a flexible, plastic-coated metal shaft with a proximal handle and an extremely sharp cutting edge at the distal tip (e.g., the distal tip may terminate in a blade which is curved at 90 degrees to the shaft, or an assembly of several thin helicoidal blades that are rotated). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
024882552
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840240938202Wexler Surgical, Inc.SA-C-RB3L2025-08-22
00840240938219Wexler Surgical, Inc.SA-C-RB4L2025-08-22
00840240938226Wexler Surgical, Inc.SA-C-RB52025-08-22
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
00840240938066Wexler Surgical, Inc.LA-FM32025-03-28
00840240938073Wexler Surgical, Inc.LA-FM3U2025-03-28
00840240938059Wexler Surgical, Inc.MA-FM32025-03-28
00840240937786Wexler Surgical, Inc.SA-CB15L2025-03-28
00840240937793Wexler Surgical, Inc.SA-CB1L2025-03-28
00840240937809Wexler Surgical, Inc.SA-CB25L2025-03-28
00840240937816Wexler Surgical, Inc.SA-CB2L2025-03-28
00840240938035Wexler Surgical, Inc.SA-CB32025-03-28
00840240937823Wexler Surgical, Inc.SA-CB35L2025-03-28
00840240937830Wexler Surgical, Inc.SA-CB3L2025-03-28
00840240937847Wexler Surgical, Inc.SA-CB42025-03-28
00840240937854Wexler Surgical, Inc.SA-CB52025-03-28
00840240937861Wexler Surgical, Inc.SA-CB62025-03-28

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00860013182304BoomerangAveera Medical Inc.MGZ2025-07-14
00860013182311BoomerangAveera Medical Inc.MGZ2025-07-14
00850041730134LimFlow VectorLimflow Inc.MGZ2024-04-12
00850041730028LimFlow VectorLimflow Inc.MGZ2023-06-26
00840663102297Eze-Sit Valvulotome Lemaitre Vascular, Inc.MGZ2022-06-30
H862TIVCNC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVH20NC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVH30NC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVK2030NC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-11
H862TIVH40NC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-11
00887482049938Symmetry Surgical®SYMMETRY SURGICAL INC.MGZ2018-09-25
00887482049945Symmetry Surgical®SYMMETRY SURGICAL INC.MGZ2018-09-25
00887482049952Symmetry Surgical®SYMMETRY SURGICAL INC.MGZ2018-09-25
00887482049969Symmetry Surgical®SYMMETRY SURGICAL INC.MGZ2018-09-25
00887482090282Symmetry Surgical®SYMMETRY SURGICAL INC.MGZ2018-09-25
00887482090299Symmetry Surgical®SYMMETRY SURGICAL INC.MGZ2018-09-25
M944AL103110Wexler Surgical, Inc.WEXLER SURGICAL, INC.MGZ2016-12-20
04057034015308Valvulotome 25cm, blade 2mm, w/ballGeister Medizintechnik GmbHMGZ2016-09-21
04057034015322Valvulotome 23cm, blade 2mm, w/ballGeister Medizintechnik GmbHMGZ2016-09-21
00846159010978SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02
00846159010985SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02
00846159010992SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02
00846159031997SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02
00846159032000SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02
H862TIVH402Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2016-08-31
H862TIVK20302Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2016-08-31
H862TIVC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2016-08-31
H862TIVH202Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2016-08-31
H862TIVH302Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2016-08-31
00840663106721Expandable LeMaitre ValvulotomeLEMAITRE VASCULAR, INC.MGZ2015-07-15