Grip for rectoscope

Primary DI
08033638800225
Brand
Grip for rectoscope
Company
SAPI MED SPA
Model
A.4131
Catalog number
A.4131
Device description
Grip for rectoscope
Published
2016-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
08033638800232PackageGS110In Commercial Distribution
08033638800225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033638800232080336388002328033638800232
08033638800225080336388002258033638800225

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument containment holder, single-use, non-sterileA non-sterile device intended to be used in the operating room (OR) by staff to safely contain/support a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] to avoid damage to the instrument during surgery and/or to enable easy transfer/handling of the instrument at reduced risk of injury. It is available in various forms (e.g., rack, rest, puncture cushion, pocket, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a single-use device intended to be sterilized prior to use.

Regulatory Flags#

DUNS number
437320088
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
08033638801550Rectoscope equipmentSAPI MED SPAKDM2023-07-27
08033638800720Rectoscope equipmentSAPI MED SPAKDM2023-07-27
08033638801567Rectoscope equipmentSAPI MED SPAKDM2023-07-27
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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