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EndoVive One Step Button

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
EndoVive One Step Button FDA UDI
Generic Name
Gastrostomy tube kit, medicated FDA UDI
Device Name
Low Profile Percutaneous Endoscopic Gastrostomy Kit FDA UDI
Model / Reference
M00563190 FDA UDI
Description
Low Profile Percutaneous Endoscopic Gastrostomy Kit FDA UDI

Identifiers

Primary DI / UDI-DI
08714729284314 FDA UDI
FDA Product Code
KGC FDA UDI
GMDN Term
Gastrostomy tube kit, medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
Commercial Distribution
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

Yes

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: Gastrostomy tube kit, medicated

EndoVive One Step Button by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrostomy tube kit, medicated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 284a2e98-2bb0-4667-9fc1-50760b4dd9dc 34 fields · synced May 30, 2026