Rectoscope equipment

Primary DI
08033638801550
Brand
Rectoscope equipment
Company
SAPI MED SPA
Model
Rectoscope equipment with insufflator
Catalog number
A.4525INS
Device description
Non sterile and disposable equipment made of 250mm rectoscope, grip and insufflator.
Published
2023-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KDMSigmoidoscope, Rigid, Non-Electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDMSigmoidoscope, Rigid, Non-ElectricalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070915000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070915000SAPIMED DISPOSABLE SIGMOIDOSCOPESapimed S.P.A.2007-07-06KDM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033638801567PackageGS120In Commercial Distribution
08033638801550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033638801567080336388015678033638801567
08033638801550080336388015508033638801550

GMDN Terms#

Term, Definition table
TermDefinition
Optical proctoscope, single-useAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during proctoscopy. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through direct or magnified viewing, or a fibreoptic bundle. This device is longer than an anoscope to provide a deeper view. This is a single-use device.

Regulatory Flags#

DUNS number
437320088
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
08033638800614Rectoscope equipmentSAPI MED SPAKDM2025-02-17
08033638800621Rectoscope equipmentSAPI MED SPAKDM2025-02-17
08033638801536Rectoscope equipmentSAPI MED SPAKDM2025-02-17
08033638800713Rectoscope equipmentSAPI MED SPAKDM2023-07-27
08033638800720Rectoscope equipmentSAPI MED SPAKDM2023-07-27
08033638801567Rectoscope equipmentSAPI MED SPAKDM2023-07-27
08033638800225Grip for rectoscopeSAPI MED SPAKDM2016-11-30
08033638800164RectoscopeSAPI MED SPAKDM2016-11-25
08033638800188RectoscopeSAPI MED SPAKDM2016-11-25
08033638800201RectoscopeSAPI MED SPAKDM2016-11-25
08033638800249RectoscopeSAPI MED SPAKDM2016-11-25
08033638800263RectoscopeSAPI MED SPAKDM2016-11-25
08033638800171RectoscopeSAPI MED SPAKDM2016-11-25
08033638800195RectoscopeSAPI MED SPAKDM2016-11-25
08033638800218RectoscopeSAPI MED SPAKDM2016-11-25
08033638800256RectoscopeSAPI MED SPAKDM2016-11-25
08033638800270RectoscopeSAPI MED SPAKDM2016-11-25
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