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Single-Site +1 more model

FDA UDI

Class II (US FDA UDI)

by Intuitive Surgical, Inc.

Identity

Trade Name
Single-Site; daVinci Si FDA UDI
Generic Name
Surgical irrigation/aspiration handpiece, reusable FDA UDI
Device Name
SUCTION IRRIGATOR FDA UDI
Model / Reference
428054 FDA UDI
Description
SUCTION IRRIGATOR FDA UDI

Identifiers

Primary DI / UDI-DI
00886874111918 FDA UDI
FDA Product Code
NAY FDA UDI
GCJ FDA UDI
GMDN Term
Surgical irrigation/aspiration handpiece, reusable FDA UDI
Models / Variants
Single-Site FDA UDI
daVinci Si FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 5 Millimeter FDA UDI

Category: Surgical irrigation/aspiration handpiece, reusable

Single-Site +1 more model by Intuitive Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS

Similar devices

Also classified as Surgical irrigation/aspiration handpiece, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Intuitive Surgical, Inc.

Sources (1)

  • FDA UDI f60ac908-134b-4af1-a75d-fb578d8bf609 34 fields · synced Jun 9, 2026