FDA.reportPublic FDA data

THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope

Primary DI
28033737710191
Brand
THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope
Company
THD SPA
Model
Bevelled Proctoscope Large Sterile
Catalog number
800006
Device description
The THD proctoscope is a disposable medical device deemed for examination and treatment of the anal and rectum Available with truncated or beveled tip.
Published
2016-12-23
Public version status
Update
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
GCPEndoscope, Ac-Powered And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCPEndoscope, Ac-Powered And AccessoriesGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121135000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121135000THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPEThd Spa2012-06-01FER

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18033737710194PackageGS115In Commercial Distribution
28033737710191PackageGS13In Commercial Distribution
08033737710197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1803373771019418033737710194
2803373771019128033737710191
08033737710197080337377101978033737710197

GMDN Terms#

Term, Definition table
TermDefinition
Optical anoscope, single-useAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. It is inserted into the body through the anus during anoscopy. The inserted portion is short in length, though longer than a sphincteroscope, and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through relayed lens optics or direct vision. This device is typically used to examine/diagnose patients suffering pain in the rectum/anus, haemorrhoids, or anal fissures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length130Millimeter
Outer Diameter26.1Millimeter

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
false
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
08051887044719THD N-Ano anoscopesTHD SPAGCP2025-03-14
08051887044733THD N-Ano anoscopeTHD SPAGCP2025-03-14
08051887044757THD N-Ano AnoscopeTHD SPAGCP2025-03-14
08051887044771THD N-ano anoscopeTHD SPAGCP2025-03-14
08033737710715THD N-ano anoscopeTHD SPAGCP2018-04-12
08033737712276THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2017-11-14
08033737710661THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2017-07-13
08033737710678THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2017-07-13
08033737710722THD N-ano anoscopeTHD SPAGCP2017-01-20
08033737710012THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710029THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710036THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710043THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710050THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710067THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710074THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710081THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710098THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710104THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710111THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710128THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710135THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710142THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710159THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710166THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710173THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710180THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710197THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710203THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23
08033737710333THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scopeTHD SPAGCP2016-12-23