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Single-Site

FDA UDI

Class II (US FDA UDI)

by Intuitive Surgical, Inc.

Identity

Trade Name
Single-Site FDA UDI
Generic Name
Robotic surgical ligation clip applier FDA UDI
Device Name
CLIP APPLIER, MEDIUM-LARGE FDA UDI
Model / Reference
478053 FDA UDI
Description
CLIP APPLIER, MEDIUM-LARGE FDA UDI

Identifiers

Primary DI / UDI-DI
00886874113585 FDA UDI
FDA Product Code
NAY FDA UDI
GCJ FDA UDI
GMDN Term
Robotic surgical ligation clip applier 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

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 5 Millimeter FDA UDI

Category: Robotic surgical ligation clip applier

Single-Site by Intuitive Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Robotic surgical ligation clip applier.

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 43e70cc9-59cf-4fe5-b6a0-46be1e8af10d 34 fields · synced Jun 9, 2026