← Back to catalogue

SureForm

FDA UDI

Class II (US FDA UDI)

by Intuitive Surgical, Inc.

Identity

Trade Name
SureForm FDA UDI
Generic Name
Robotic surgical cutting stapler, single-use FDA UDI
Device Name
SureForm 45 FDA UDI
Model / Reference
480445 FDA UDI
Description
SureForm 45 FDA UDI

Identifiers

Primary DI / UDI-DI
00886874117583 FDA UDI
FDA Product Code
GDW FDA UDI
NAY FDA UDI
GMDN Term
Robotic surgical cutting stapler, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4750 FDA UDI
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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 14 Millimeter FDA UDI

Category: Robotic surgical cutting stapler, single-use

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

Similar devices

Also classified as Robotic surgical cutting stapler, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Intuitive Surgical, Inc.

Sources (1)

  • FDA UDI 084a4ab9-722f-4252-9b99-ef4007b62cb8 34 fields · synced Jun 9, 2026