FDA.reportPublic FDA data

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
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MGZValvulotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGZValvulotomeCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M944AL103010PrimaryHIBCC0
00840240907567SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840240907567008402409075678402409075670840240907567

Sterilization Methods#

Method table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M944FL051010Wexler Surgical, Inc.FL0510.12026-10-30
M944SL712210Wexler Surgical, Inc.SL7122.12026-10-30
M944SL712410Wexler Surgical, Inc.SL7124.12026-10-30
M944SL712510Wexler Surgical, Inc.SL7125.12026-10-30
M944TL034010Wexler Surgical, Inc.TL0340.12026-10-30
M944TL034110Wexler Surgical, Inc.TL0341.12026-10-30
M944TL034210Wexler Surgical, Inc.TL0342.12026-10-30
M944TL034310Wexler Surgical, Inc.TL0343.12026-10-30
M944TL034410Wexler Surgical, Inc.TL0344.12026-10-30
M944TL034510Wexler Surgical, Inc.TL0345.12026-10-30
M944TL034610Wexler Surgical, Inc.TL0346.12026-10-30
M944TL034710Wexler Surgical, Inc.TL0347.12026-10-30
M944TL034810Wexler Surgical, Inc.TL0348.12026-10-30
M944TL034910Wexler Surgical, Inc.TL0349.12026-10-30
M944TL036110Wexler Surgical, Inc.TL0361.12026-10-30
M944TL044610Wexler Surgical, Inc.TL0446.12026-10-30
M944TL044710Wexler Surgical, Inc.TL0447.12026-10-30
M944TL072010Wexler Surgical, Inc.TL0720.12026-10-30
M944TL072210Wexler Surgical, Inc.TL0722.12026-10-30
M944TL845110Wexler Surgical, Inc.TL8451.12026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD491118070Surgical DirectSurgical Direct, Inc.MGZ2026-10-22
00190776433796MillenniumAvalign Technologies, Inc.MGZ2026-10-08
00190776433802MillenniumAvalign Technologies, Inc.MGZ2026-10-08
00190776433819MillenniumAvalign Technologies, Inc.MGZ2026-10-08
B382SD4911930Surgical DirectSurgical Direct, Inc.MGZ2026-08-04
B382SD491118030Surgical DirectSurgical Direct, Inc.MGZ2026-08-04
00860013182304BoomerangAveera Medical Inc.MGZ2025-07-14
00860013182311BoomerangAveera Medical Inc.MGZ2025-07-14
00850041730134LimFlow VectorInari Medical, Inc.MGZ2024-04-12
00850041730028LimFlow VectorInari Medical, Inc.MGZ2023-06-26
00840663102297Eze-Sit ValvulotomeLemaitre Vascular, Inc.MGZ2022-06-30
H862TIVCNC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVH20NC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVH30NC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
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
H862TIVH40NC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-11
H862TIVK2030NC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-11
H862TIVK2030NC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-11
H862TIVH40NC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-11
00887482049938Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482049945Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482049952Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482049969Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482090282Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482090299Symmetry SurgicalASPEN SURGICAL PRODUCTS, 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