FDA.reportPublic FDA data

Dilatan Plus

Primary DI
08033638800355
Brand
Dilatan Plus
Company
SAPI MED SPA
Model
Dilators 23/27 mm diameter
Catalog number
A.1002
Published
2023-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FFPDilator, Rectal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFPDilator, RectalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033638803943PackageGS112In Commercial Distribution
08033638800355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033638803943080336388039438033638803943
08033638800355080336388003558033638800355

GMDN Terms#

Term, Definition table
TermDefinition
Rectal dilator, reusableA surgical instrument designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument. This is a reusable device.

Regulatory Flags#

DUNS number
437320088
Device count
1
Premarket exempt
true
Lot or batch
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
00850005838449Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838456Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838463Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838487Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838494Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838500Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838517Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838524Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838531Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838548Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838555Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
G586UR6213360Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR6214120Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR6214140Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR96214120Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR96214130Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR96214140Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
00842331194603Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6216100Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6216160Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217120Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217130Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217140Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217150Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217210Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217220Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217230Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217240Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
08033638801147DilastomSAPI MED SPAFFP2023-08-02
08033638803929DilastomSAPI MED SPAFFP2023-08-02