Single-Site

FDA UDI

Class II (US FDA UDI)

by Intuitive Surgical, Inc.

Identity

Trade Name: Single-Site FDA UDI
Generic Name: Robotic surgical forceps, reusable FDA UDI
Device Name: CROCKODILE GRASPER FDA UDI
Model / Reference: 478059 FDA UDI
Description: CROCKODILE GRASPER FDA UDI

Identifiers

Primary DI / UDI-DI: 00886874113639 FDA UDI
FDA Product Code: GCJ FDA UDI
NAY FDA UDI
GMDN Term: Robotic surgical forceps, reusable 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 5 Millimeter FDA UDI

Category: Robotic surgical forceps, reusable

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 forceps, reusable.

Kocher Grasper Ø 5 mm x 310 mm — Asensus Surgical Italia S.r.l. · Class IIa
Fundus Grasper Ø 5 mm x 240 mm — Asensus Surgical Italia S.r.l. · Class IIa
Toumai — Shanghai MicroPort MedBot (Group) Co., Ltd. · Class I
Right Angle Dissector, Long Ø 10 mm x length 410 mm — Asensus Surgical Italia S.r.l. · Class IIa
Monopolar L-Hook Electrode Ø 5 mm x 410 mm — Asensus Surgical Italia S.r.l. · Class IIa
Toumai — Shanghai MicroPort MedBot (Group) Co., Ltd. · Class IIb
Needle Holder Left Ø 5 mm x 310 mm — Asensus Surgical Italia S.r.l. · Class IIa
Monopolar energy instrument cord — Shenzhen Edge Medical Co., Ltd. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Intuitive Surgical, Inc.

Sources (1)

FDA UDI e8c269bb-a22a-425b-8cc2-e5759fa94233 34 fields · synced Jun 9, 2026