FDA.reportPublic FDA data

Expandable LeMaitre Valvulotome

Primary DI
00840663106721
Brand
Expandable LeMaitre Valvulotome
Company
Lemaitre Vascular, Inc.
Model
e1096-00
Catalog number
e1096-00
Device description
1.8mm Expandable LeMaitre Valvulotome, 40 cm, eIFU
Published
2015-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
00840663106721PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840663106721008406631067218406631067210840663106721

GMDN Terms#

Term, Definition table
TermDefinition
Valvulotome, reusableA 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.

Contacts#

Phone, Email table
PhoneEmail
781-221-2266xx@xx.xx

Regulatory Flags#

DUNS number
184805166
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840663102297Eze-Sit Valvulotome94cmTIVK20302022-06-30
00840663100095Expandable LeMaitre Valvulotome1000-901000-902015-06-30
00840663100101Expandable LeMaitre Valvulotomee1000-90e1000-902015-06-30
00840663100118Expandable LeMaitre Valvulotome1000-951000-952015-06-30
00840663100132Over-the-Wire LeMaitre Valvulotome1005-001005-002015-06-30
00840663100149Over-the-Wire LeMaitre Valvulotomee1005-00e1005-002015-06-30
00840663100163Over-the-Wire LeMaitre Valvulotome1006-001006-002015-06-30
00840663100309Expandable LeMaitre Valvulotome1096-001096-002015-06-30
00840663106653HYDRO LeMaitre Valvulotome1009-001009-002015-06-30
00840663106660HYDRO LeMaitre Valvulotome1010-001010-002015-06-30
00840663106820Hydro LeMaitre Valvulotomee1009-00e1009-002015-07-15
00840663106837Hydro LeMaitre Valvulotomee1010-00e1010-002015-07-15
00840663107315Retrograde LeMills Valvulotome1050-001050-002015-06-30
00840663107322Antegrade LeMills Valvulotome1050-011050-012015-06-30
00840663107339Antegrade and Retrograde LeMills Valvulotome1050-021050-022015-06-30
00840663107346Retrograde LeMills Valvulotomee1050-00e1050-002015-06-30
00840663107353Antegrade LeMills Valvulotomee1050-01e1050-012015-06-30
00840663107360Antegrade and Retrograde LeMills Valvulotomee1050-02e1050-022015-06-30
00840663110360AlboGraft Polyester Vascular Graft ATC6034ATC60342021-06-18
00840663110377AlboGraft Polyester Vascular Graft ATC6038ATC60382021-06-18

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
M944AL103010Wexler Surgical, Inc.WEXLER SURGICAL, INC.MGZ2016-12-19
04057034015308Valvulotome 25cm, blade 2mm, w/ballGeister Medizintechnik GmbHMGZ2016-09-21