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Navigator

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
Navigator FDA UDI
Generic Name
Endoscopic-access dilator, single-use FDA UDI
Device Name
Ureteral Access Sheath Set FDA UDI
Model / Reference
M0062502020 FDA UDI
Description
Ureteral Access Sheath Set FDA UDI

Identifiers

Primary DI / UDI-DI
08714729429944 FDA UDI
FDA Product Code
KOD FDA UDI
FED FDA UDI
GMDN Term
Endoscopic-access dilator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5130 FDA UDI
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

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

Category: Endoscopic-access dilator, single-use

Navigator by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic-access dilator, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 8108ad29-3534-4dbc-851a-b8ccd8207630 34 fields · synced May 31, 2026