Rectoscope

Primary DI
08033638800263
Brand
Rectoscope
Company
SAPI MED SPA
Model
A.4522
Catalog number
A.4522
Device description
Multi-purpose rectoscope
Published
2016-11-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
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
08033638800270PackageGS112In Commercial Distribution
08033638800263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033638800270080336388002708033638800270
08033638800263080336388002638033638800263

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
437320088
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
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
08033638800430Self-light anoscopesSELF-LIGHT SCOPEA.40222023-07-27
08033638800478Self-light anoscopesOperative Self-Led-Light A.4023.1L2023-07-27

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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
08033638801550Rectoscope equipmentSAPI MED SPAKDM2023-07-27
08033638800720Rectoscope equipmentSAPI MED SPAKDM2023-07-27
08033638801567Rectoscope equipmentSAPI MED SPAKDM2023-07-27
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08033638800164RectoscopeSAPI MED SPAKDM2016-11-25
08033638800188RectoscopeSAPI MED SPAKDM2016-11-25
08033638800201RectoscopeSAPI MED SPAKDM2016-11-25
08033638800249RectoscopeSAPI 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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