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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
Laparoscopic multi-instrument access port, single-use FDA UDI
Device Name
ENDOSCOPE PORT FDA UDI
Model / Reference
428065 FDA UDI
Description
ENDOSCOPE PORT FDA UDI

Identifiers

Primary DI / UDI-DI
00886874112014 FDA UDI
FDA Product Code
GCJ FDA UDI
NAY FDA UDI
GMDN Term
Laparoscopic multi-instrument access port, single-use 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 8.5 Millimeter FDA UDI

Category: Laparoscopic multi-instrument access port, single-use

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

Similar devices

Also classified as Laparoscopic multi-instrument access port, single-use.

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 cba7fd85-56bc-4659-bfa4-798340c6ca29 34 fields · synced Jun 9, 2026