FDA.reportPublic FDA data

HEMORRHOID LIGATOR

Primary DI
00192896044807
Brand
HEMORRHOID LIGATOR
Company
SONTEC INSTRUMENTS, INC.
Model
508-585
Device description
HEMORRHOID LIGATOR SELF-LOADING WITH LOADING CONE STRAIGHT
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
B0995085850PreviousHIBCC0
00192896044807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896044807001928960448071928960448070192896044807

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
Length9.5Inch

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat 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
00192896040885Antrum Grasping Forceps468-360468-3602018-09-10
00192896123861Sheen Mini Cartilage Cutting Block350-845M350-845M2026-10-14
00192896123878Allis Tissue Forceps140-331Q140-331Q2026-10-14
00192896123885Allis Tissue Forceps140-330AQ140-330AQ2026-10-14
00192896123892Ceramitec Debakey Forceps2200-168CL2200-168CL2026-10-14
00192896123908Debakey Forceps2200-168L2200-168L2026-10-14
00192896123915Ceramitec Debakey Forceps2200-172CL2200-172CL2026-10-14
00192896123922Knurled Nut2500-200-1B2500-200-1B2026-10-14
00192896123939Bishop Harmon Tissue Forceps14-380114-38012026-10-14
00192896097049Laparoscopic Bulldog Clamp Forceps2901-2812901-2812019-05-09
00192896097056Laparoscopic Bulldog Clamp2901-281-252901-281-252019-05-09
00192896097063Laparoscopic Bulldog Clamp2901-281-402901-281-402019-05-09
00192896123793Adson Tissue Forceps140-302DLQ140-302DLQ2026-10-06
00192896123809Micro Skinner Forceps140-519M140-519M2026-10-06
00192896123816Jacobson Needle Holder2300-142D2300-142D2026-10-06
00192896123823Thumb Dressing Forceps136-610Q136-610Q2026-10-06
00192896123830Thumb Dressing Forceps136-615Q136-615Q2026-10-06
00192896123847Thumb Dressing Forceps136-619Q136-619Q2026-10-06
00192896123854Gum Scissors475-153Q475-153Q2026-10-06
00192896111394Laparoscopic Bulldog Clamp2901-281-60T2901-281-60T2021-10-22

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Primary DI, Brand, Company table
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