FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD917821110
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD91782111
Catalog number
SD91782111
Device description
7” McGivney Hemorrhoidal Ligator, Includes Cone
Published
2024-03-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHNLigator, hemorrhoidal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHNLigator, HemorrhoidalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD917821110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haemorrhoid ligatorA hand-held manual surgical instrument designed to deploy a ligature (e.g., a latex rubber band) to internal haemorrhoids for their removal through blood flow occlusion. It is typically made of high-grade stainless steel, and has a long shaft with a profiled clamp or grip at the distal end for holding multiple ligatures. The surgeon mechanically operates the distal clamp or grip with a handle(s) to release and deploy the ligatures as needed. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 519-3293info@surgicaldirect.com

Regulatory Flags#

DUNS number
124367223
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
B382SD155310120Surgical DirectSD15531012SD155310122026-07-23
B382SD155310140Surgical DirectSD15531014SD155310142026-07-23
B382SD1553600Surgical DirectSD155360SD1553602026-07-23
B382SD9017971040Surgical DirectSD901797104SD9017971042026-07-23
B382SD9029931060Surgical DirectSD902993106SD9029931062026-07-23
B382SD905701100Surgical DirectSD90570110SD905701102026-07-23
B382SD9114061030Surgical DirectSD911406103SD9114061032026-07-23
B382SD911424030Surgical DirectSD91142403SD911424032026-07-23
B382SD911424050Surgical DirectSD91142405SD911424052026-07-23
B382SD911424060Surgical DirectSD91142406SD911424062026-07-23
B382SD9114241000Surgical DirectSD911424100SD9114241002026-07-23
B382SD9114251000Surgical DirectSD911425100SD9114251002026-07-23
B382SD91143009NC0Surgical DirectSD91143009NCSD91143009NC2026-07-23
B382SD9114301120Surgical DirectSD911430112SD9114301122026-07-23
B382SD91143012NC0Surgical DirectSD91143012NCSD91143012NC2026-07-23
B382SD9114311010Surgical DirectSD911431101SD9114311012026-07-23
B382SD9114311060Surgical DirectSD911431106SD9114311062026-07-23
B382SD9114311080Surgical DirectSD911431108SD9114311082026-07-23
B382SD911437070Surgical DirectSD91143707SD911437072026-07-23
B382SD91143709NC0Surgical DirectSD91143709NCSD91143709NC2026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046955063413AESCULAPAESCULAP, INC.FHN2026-06-06
05055445961923SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961947SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961954SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961961SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961978SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961985SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961992SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445962005SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05060937770006Haemoband-PLUS Band LigatorHaemoband SurgicalFHN2026-04-28
00860014651106LHC Power Bander LHC Power Bander LLCFHN2026-03-03
00860014651113LHC Power Bander LHC Power Bander LLCFHN2026-03-03
06932503532853Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532860Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
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06932503532907Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532914Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532938Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532945Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532850Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532867Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532874Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532881Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532898Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532904Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532911Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532935Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532942Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14