FDA.reportPublic FDA data

Anoscope

Primary DI
08033638800034
Brand
Anoscope
Company
SAPI MED SPA
Model
A.4019
Catalog number
A.4019
Device description
Self-Light Diagnostic Proctoscope
Published
2016-11-25
Public version status
Update
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
FERAnoscope And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FERAnoscope And AccessoriesGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070913000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070913000SELF-LIGHT DISPOSABLE ANOSCOPESapimed S.P.A.2007-08-10FER

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033638800034PackageGS175In Commercial Distribution
08033638800027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033638800034080336388000348033638800034
08033638800027080336388000278033638800027

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
437320088
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
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
08033638801710Self-Suction-LEMSelf-Suction-LEMA.56702026-02-06
08033638802861Self-light anoscopesSelf-led-light diagnostic anoscope + Led lightA.4018L2026-02-06
08033638801727Self-Suction-LEMSelf-Suction-LEMA.56702026-02-06
08033638802878Self-light anoscopesSelf-led-light diagnostic anoscope + Led lightA.4018L2026-02-06
08033638800614Rectoscope equipmentRectoscope equipment with LED and insufflatorA.4513LINS2025-02-17
08033638800621Rectoscope equipmentRectoscope equipment with LED and insufflatorA.4513LINS2025-02-17
08033638801536Rectoscope equipmentRectoscope equipment with LED and insufflatorA.4520LINS2025-02-17
08033638800027AnoscopeA.4019A.40192016-11-25
08033638800041AnoscopeA.4023.1A.4023.12016-11-25
08033638800065AnoscopeA.4024.1A.4024.12016-11-25
08033638800089RetractorA.4081A.40812016-11-25
08033638800102RetractorA.4082A.40822016-11-25
08033638800126RetractorA.4083A.40832016-11-25
08033638800140RetractorA.4084A.40842016-11-30
08033638800164RectoscopeA.4113A.41132016-11-25
08033638800188RectoscopeA.4120A.41202016-11-25
08033638800201RectoscopeA.4125A.41252016-11-25
08033638800249RectoscopeA.4519A.45192016-11-25
08033638800263RectoscopeA.4522A.45222016-11-25
08033638800430Self-light anoscopesSELF-LIGHT SCOPEA.40222023-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060937770013SleeveLUX 24 Anoscope/ProctoscopeHaemoband SurgicalFER2026-04-28
05060937770020SleeveLUX 16 Anoscope/ProctoscopeHaemoband SurgicalFER2026-04-28
08033638802861Self-light anoscopesSAPI MED SPAFER2026-02-06
08033638802878Self-light anoscopesSAPI MED SPAFER2026-02-06
00860012876808Air AssistGASTRO CONCEPTS LLCFER2025-03-17
08051887044719THD N-Ano anoscopesTHD SPAFER2025-03-14
08051887044733THD N-Ano anoscopeTHD SPAFER2025-03-14
08051887044757THD N-Ano AnoscopeTHD SPAFER2025-03-14
08051887044771THD N-ano anoscopeTHD SPAFER2025-03-14
18051887044730THD N-Ano anoscopeTHD SPAFER2025-03-14
18051887044754THD N-Ano AnoscopeTHD SPAFER2025-03-14
08033638801192AdaptorSAPI MED SPAFER2023-08-02
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
08033638800447Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638803585Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638801260Self-light anoscopesSAPI MED SPAFER2023-07-27
08033638801369EpoflierSAPI MED SPAFER2023-07-27
08033638802892Self-light anoscopesSAPI MED SPAFER2023-07-27
00732094007657Welch Allyn, Inc.WELCH ALLYN, INC.FER2023-04-27
00732094239331Welch Allyn, Inc.WELCH ALLYN, INC.FER2023-04-25
04053755200436INSTRUMENT HEAD FOR UNISPEC TUBESHeine Optotechnik GmbH & Co. KGFER2023-01-11
00732094007626Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-05-07
00732094128208Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-05-07
00732094007664Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-04-26
00732094009828Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-04-26
00732094007541Welch Allyn, Inc.WELCH ALLYN, INC.FER2021-04-15