← Back to catalogue

Pigalileo

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
PIGALILEO FDA UDI
Generic Name
Optical surgical navigation device tracking system FDA UDI
Device Name
PLUS PIGALILEO NAV PIGALILEO MINI .ASSEM FDA UDI
Model / Reference
75006787 FDA UDI
Description
PLUS PIGALILEO NAV PIGALILEO MINI .ASSEM FDA UDI

Identifiers

Catalog Number
75006787 FDA UDI
Primary DI / UDI-DI
07611996099201 FDA UDI
510(k) Number
K080875 FDA UDI
FDA Product Code
HAW FDA UDI
GMDN Term
Optical surgical navigation device tracking system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 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

Category: Optical surgical navigation device tracking system

Pigalileo by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Optical surgical navigation device tracking system.

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
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI 5afefbdd-7a9e-4daa-9b9d-63e150f3fa6e 36 fields · synced Jun 8, 2026