FDA.reportPublic FDA data

THD Bandy

Primary DI
08033737710685
Brand
THD Bandy
Company
THD SPA
Model
THD Bandy
Catalog number
800079
Device description
THD Bandy is a disposable suction ligator for the treatment of haemorrhoidal disease, ready to use. No cleaning or disinfection required.THD Disposable comes in single packing (single use), including ligator, 4 rings, and loading system.THD Bandy connects to a suction system, while it is possible to control the quality of aspirated tissue, around which the elastic band will be released by pulling the trigger
Published
2016-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHNLigator, Hemorrhoidal

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093497000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093497000THD BANDYThd Spa2010-07-15FHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18033737710682PackageGS110In Commercial Distribution
08033737710685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1803373771068218033737710682
08033737710685080337377106858033737710685

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length154Millimeter
Outer Diameter12.8Millimeter

Contacts#

Phone, Email table
PhoneEmail
+390522634311Regulatory@thdlab.com

Regulatory Flags#

DUNS number
338430324
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033737710777THD SLIDE ONETHD OPTI-FIBER (REVO/BT)8800122022-09-01
18033737710781THD SLIDE ONETHD OPTI-FIBER (EVO/BT)8800182022-09-09
08051887049837THD BIOPSYTHD BIOPSY (GI)8003002026-01-07
08051887049851THD BIOPSYTHD BIOPSY (J)8003172026-01-07
08051887049875THD BIOPSYTHD BIOPSY (GI - XL)8003282026-01-07
18051887049841THD BIOPSYTHD BIOPSY (GI)8003002026-01-07
18051887049865THD BIOPSYTHD BIOPSY (J)8003172026-01-07
18051887049889THD BIOPSYTHD BIOPSY (GI - XL)8003282026-01-07
08033737710869THD SLIDE ONETHD SLIDE7100042025-10-30
18033737710354THD SLIDE ONETHD DOPPLER PROBE (1s/ST)8000632025-10-30
08051887047918THD SLIDE ONETHD ANOLIFT US8003302025-04-03
18051887047915THD SLIDE ONETHD ANOLIFT US8003302025-04-03
08051887044719THD N-Ano anoscopesTHD N-ANO DIGITAL (TR)8003132025-03-14
08051887044733THD N-Ano anoscopeTHD N-ANO DIGITAL (BE)8003142025-03-14
08051887044757THD N-Ano AnoscopeTHD N-ANO DIGITAL MAXI (TR)8003152025-03-14
08051887044771THD N-ano anoscopeTHD N-ANO DIGITAL MAXI (BE)8003162025-03-14
18051887044716THD N-Ano anoscopesTHD N-ANO DIGITAL (TR)8003132025-03-14
18051887044730THD N-Ano anoscopeTHD N-ANO DIGITAL (BE)8003142025-03-14
18051887044754THD N-Ano AnoscopeTHD N-ANO DIGITAL MAXI (TR)8003152025-03-14
18051887044778THD N-ano anoscopeTHD N-ANO DIGITAL MAXI (BE)8003162025-03-14

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