FDA.reportPublic FDA data

THD BIOPSY

Primary DI
18051887047410
Brand
THD BIOPSY
Company
THD SPA
Model
THD BIOPSY (GI - XL)
Catalog number
800328
Device description
THD BIOPSY are disposable rigid biopsy forceps for use with THD anoscopes and rectoscopes during various diagnostic and surgical procedures of the anal canal and/or rectum. THD BIOPSY are equipped with a rotating ring nut that allows the instrument to be rotated and oriented during the procedure, facilitating the access from different angles.
Published
2025-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCLForceps, Biopsy, Non-Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18051887047410PackageGS110In Commercial Distribution
08051887047413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805188704741018051887047410
08051887047413080518870474138051887047413

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic biopsy forceps, single-useA rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length34Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
338430324
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664900000NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664900215NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664900222NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910788NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910801NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910832NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910863NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911365NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911372NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911389NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911396NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944035NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944042NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944059NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944066NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944073NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944080NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944097NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944103NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944110NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944127NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944134NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944141NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944165NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944172NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06975339628512Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03
06975339628529Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03
06975339628536Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03
06975339628550Single-Use Grasping ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03
06975339628567Single-Use Grasping ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03