FDA.reportPublic FDA data

In-Sight

Primary DI
00858276007410
Brand
In-Sight
Company
Micro-tech Usa
Model
MDHL100000A
Device description
In-Sight Multi-Band Ligator
Published
2025-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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
00858276007410PackageGS110In Commercial Distribution
00858276007427PackageGS14In Commercial Distribution
00858276007403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858276007410008582760074108582760074100858276007410
00858276007427008582760074278582760074270858276007427
00858276007403008582760074038582760074030858276007403

GMDN Terms#

Term, Definition table
TermDefinition
Haemorrhoid ligation setA collection of sterile surgical instruments and materials used to locally occlude the blood flow to internal haemorrhoids for their removal. The collection typically includes a ligator preloaded with several ligatures (e.g., latex rubber bands) deployed to the haemorrhoids, an anoscope used to dilate the anus for internal access, and an obturator for insertion of the anoscope. After a ligature has been applied, the haemorrhoid will eventually necrose and pass out of the gut naturally. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079873914
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858276007700Polyp Trap single chamber bulkPT50-50-S2025-09-09
10858276007707Polyp Trap single chamber bulkPT50-50-S2025-09-09
00850025860857CO2 Source Tubing Adapter Olympus UCRBW02-CO2CONOLY2025-05-12
00850025860864CO2 Source Tubing Adapter Fuji GW100BW02-CO2CONFJ2025-05-12
00850025860901CO2 Source Tubing Filter Adapter OlympusBW02-CO2TUBAOLY2025-05-12
00858276007977CO2 Source Tubing Filter OlympusBW02-CO2TUBOLY2025-05-12
00858276007984Endoscopy Kit - Compliance+ FUJ5 KitKT1A0010A2025-05-12
10850025860854CO2 Source Tubing Adapter Olympus UCRBW02-CO2CONOLY2025-05-12
10850025860861CO2 Source Tubing Adapter Fuji GW100BW02-CO2CONFJ2025-05-12
10850025860908CO2 Source Tubing Filter Adapter OlympusBW02-CO2TUBAOLY2025-05-12
10858276007974CO2 Source Tubing Filter OlympusBW02-CO2TUBOLY2025-05-12
10858276007981Endoscopy Kit - Compliance+ FUJ5 KitKT1A0010A2025-05-12
00850025860802Scope Tip ProtectorBW03-DTPS2025-03-11
00850025860819Scope Tip ProtectorBW03-DTPL2025-03-11
10850025860809Scope Tip ProtectorBW03-DTPS2025-03-11
10850025860816Scope Tip ProtectorBW03-DTPL2025-03-11
00850025860420Irrigation Tubing SetAW02-OLYTUB2025-03-07
00850025860437Irrigation Tubing SetAW02-OLYTUB2025-03-07
00858276007557Sterile Bacteriostatic Lubricating GelMDJL1A0001A2025-03-05
00850025860390Air/Water Bottle CO2 TubingAW02-OLYC022025-03-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05055445961978SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961985SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961992SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445962005SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
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16932503532904Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
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