FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD4911930
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD49-1193
Catalog number
SD49-1193
Device description
7" Antegrade Valvulotome, 1mm
Published
2026-08-04
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

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
B382SD4911930PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(386) 738-1202info@surgicaldirect.com

Regulatory Flags#

DUNS number
124367223
Device count
1
DM exempt
false
Premarket exempt
true
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
B382SD13517450Surgical DirectSD 1351745SD 13517452026-10-28
B382SD13518130Surgical DirectSD13518-13SD13518-132026-10-28
B382SD15908130Surgical DirectSD15908-13SD15908-132026-10-28
B382SD161310590Surgical DirectSD16131059SD161310592026-10-28
B382SD48310090Surgical DirectSD48-31009SD48-310092026-10-28
B382SD4865700Surgical DirectSD48-6570SD48-65702026-10-28
B382SD6200420Surgical DirectSD62-0042SD62-00422026-10-28
B382SD6200430Surgical DirectSD62-0043SD62-00432026-10-28
B382SD62372600Surgical DirectSD62-37260SD62-372602026-10-28
B382SD62372610Surgical DirectSD62-37261SD62-372612026-10-28
B382SD62372620Surgical DirectSD62-37262SD62-372622026-10-28
B382SD62372700Surgical DirectSD62-37270SD62-372702026-10-28
B382SD62372710Surgical DirectSD62-37271SD62-372712026-10-28
B382SD62372720Surgical DirectSD62-37272SD62-372722026-10-28
B382SD62373320Surgical DirectSD62-37332SD62-373322026-10-28
B382SD62373340Surgical DirectSD62-37334SD62-373342026-10-28
B382SD62373360Surgical DirectSD62-37336SD62-373362026-10-28
B382SD67371410Surgical DirectSD67-37141SD67-371412026-10-28
B382SD6787200Surgical DirectSD67-8720SD67-87202026-10-28
B382SD77505940Surgical DirectSD77505-94SD77505-942026-10-28

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
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
04057034015322Valvulotome 23cm, blade 2mm, w/ballGeister Medizintechnik GmbHMGZ2016-09-21