FDA.reportPublic FDA data

MCGIVNEY HEMORRHOIDAL LIGATOR

Primary DI
00192896044678
Brand
MCGIVNEY HEMORRHOIDAL LIGATOR
Company
SONTEC INSTRUMENTS, INC.
Model
508-550
Device description
MCGIVNEY HEMORRHOIDAL LIGATOR WITH LOADING CONE &100 O-RINGS
Published
2018-09-06
Public version status
New
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
B0995085500PreviousHIBCC0
00192896044678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896044678001928960446781928960446780192896044678

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"

Contacts#

Phone, Email table
PhoneEmail
800-821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
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
00192896056282ALLIGATOR FORCEPS1271-0101271-0102018-09-27
00192896123755Debakey-Diethrich Tissue Forceps442-239P442-239P2026-09-18
00192896123762TAVR Removal Set2400-200-SET2400-200-SET2026-09-18
00192896123779Waever Chalazion Forceps14-988014-98802026-09-18
00192896123786Prince Trachoma Eye Forceps14-968014-96802026-09-18
00192896123632Adson Dressing Forceps140-299S140-299S2026-08-27
00192896123649Converse Scissors460-156L460-156L2026-08-27
00192896123656Ferguson Abdominal Scissors110-287110-2872026-08-27
00192896123663Meyerding Finger Retractor205-856Q205-856Q2026-08-27
00192896123670Meyerding Finger Retractor205-857Q205-857Q2026-08-27
00192896122499Cartilage Graft Cutter350-842350-8422025-11-21
00192896122048Ceramitec Universal Klick Ferris Smith Rongeur Shaft404-312B404-312B2026-08-25
00192896123564Castroviejo Corneal Scissors13-2540F13-2540F2026-07-27
00192896123571Adson Needle Holding Forceps140-300140-3002026-07-27
00192896123557Debakey Neonatal Clamp2100-580B2100-580B2026-07-10
00192896078819FERRIS-SMITH KERRISON404-682404-6822018-09-20
00192896117129Meeker Hemostatic Forceps2200-440Q2200-440Q2024-03-25
00192896123502Stefan Bone Holding Forceps1103-011Q1103-011Q2026-06-24
00192896123519Rochester Carmalt Forceps1100-150L1100-150L2026-06-24
00192896123526Rochester Carmalt Forceps1100-150LQ1100-150LQ2026-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423629MillenniumAvalign Technologies, Inc.FHN2026-08-07
00190776423636MillenniumAvalign Technologies, Inc.FHN2026-08-07
00190776423643MillenniumAvalign Technologies, Inc.FHN2026-08-07
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
06932503532877Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532884Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532891Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
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