Compass International

FDA UDI

Class II (US FDA UDI)

by Compass International

Identity

Trade Name: Compass International FDA UDI
Generic Name: Neurological stereotactic surgery system FDA UDI
Device Name: Plastic Sleeve with Nut - Short White FDA UDI
Model / Reference: PL-S-10 FDA UDI
Description: Plastic Sleeve with Nut - Short White FDA UDI

Identifiers

Catalog Number: PL-S-10 FDA UDI
Primary DI / UDI-DI: B169PLS100 FDA UDI
FDA Product Code: HAW FDA UDI
GMDN Term: Neurological stereotactic surgery 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Neurological stereotactic surgery system

Compass International by Compass International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neurological stereotactic surgery system.

Gauge for Softouch Registration Pointer — Brainlab SE · Class I
PEEK INSTRUMENT ADAPTOR Ø2.15MM — MEDTECH LLC · Class II
Mini-Bolt VUE Accessory Kit — MONTERIS MEDICAL CORP · Class I
StealthAiR™ Spine — MEDTRONIC NAVIGATION, INC. · Class II
StealthStation — MEDTRONIC NAVIGATION, INC. · Class II
OsteoMed™ Manual Driver Handle — FHC, INC. · Class II
PMT CORPORATION - STEREOTACTIC — Pmt Corp. · Class II
Leksell Stereotactic System — Elekta Instrument AB · Class II

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

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

Manufacturer

Manufacturer: Compass International

Sources (1)

FDA UDI 5ca55280-b49d-4b83-8712-782ed2983f1d 34 fields · synced May 30, 2026