FDA.reportPublic FDA data

THD N-ano anoscope

Primary DI
08051887044771
Brand
THD N-ano anoscope
Company
THD SPA
Model
THD N-ANO DIGITAL MAXI (BE)
Catalog number
800316
Device description
THD N-ano Digital is a disposable medical device shaped so that it can be easily inserted into the anal cavity and which integrates in the handle the seat for a dedicated slide for association of anoscope with THD DIGITAL MINICAM which allowing HD resolution shooting of the anoscopy examination.THD N-ANO DIGITAL anoscope is supplied with a convenient introducer, a camera slide and a camera protection bag.
Published
2025-03-14
Public version status
New
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
FERAnoscope And Accessories
GCPEndoscope, Ac-Powered And Accessories

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133687000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133687000THD N-ANO ANOSCOPEThd Spa2013-12-11FER

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18051887044778PackageGS150In Commercial Distribution
08051887044771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805188704477818051887044778
08051887044771080518870447718051887044771

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
Length91Millimeter
Outer Diameter25.8Millimeter

Contacts#

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

Regulatory Flags#

DUNS number
338430324
Device count
1
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
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
08051887043286THD DIGITAL MINICAMTHD DIGITAL MINICAM8003052025-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033638802861Self-light anoscopesSAPI MED SPAFER2026-02-06
08051887044719THD N-Ano anoscopesTHD SPAFER2025-03-14
08051887044719THD N-Ano anoscopesTHD SPAGCP2025-03-14
08051887044733THD N-Ano anoscopeTHD SPAFER2025-03-14
08051887044733THD N-Ano anoscopeTHD SPAGCP2025-03-14
08051887044757THD N-Ano AnoscopeTHD SPAFER2025-03-14
08051887044757THD N-Ano AnoscopeTHD SPAGCP2025-03-14
08033638800430Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638800478Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638800485Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638801352EpoflierSAPI MED SPAFER2023-07-27
08033638802885Self-light anoscopesSAPI MED SPAFER2023-07-27
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10885380052187CARDINAL HEALTHCardinal Health 200, LLCFER2019-05-29
10885380052200CARDINAL HEALTHCardinal Health 200, LLCFER2019-05-29
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