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Navina™ Catheter set Small

FDA UDI

Class II (US FDA UDI)

by Wellspect AB

Identity

Trade Name
Navina™ Catheter set Small FDA UDI
Generic Name
Rectal irrigation system catheter FDA UDI
Device Name
Navina Transanal Irrigation. Rectal Catheter set small. 10 Rectal catheters small. Single use. Non sterile Device. Rx Only. FDA UDI
Model / Reference
68943 FDA UDI
Description
Navina Transanal Irrigation. Rectal Catheter set small. 10 Rectal catheters small. Single use. Non sterile Device. Rx Only. FDA UDI

Identifiers

Catalog Number
6894340 FDA UDI
Primary DI / UDI-DI
07392532243837 FDA UDI
FDA Product Code
KNT FDA UDI
FCE FDA UDI
GMDN Term
Rectal irrigation system catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
876.5210 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Navina™ Catheter set Small by Wellspect AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wellspect AB

Sources (1)

  • FDA UDI 2b7d436e-91ad-49d7-84f6-35c34904b330 37 fields · synced May 30, 2026