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Cranial LOOP

FDA UDI

Class II (US FDA UDI)

by Neos Surgery Sl

Identity

Trade Name
Cranial LOOP FDA UDI
Generic Name
Cranial bur hole cover FDA UDI
Device Name
Cranial Fixation System FDA UDI
Model / Reference
FC050000 FDA UDI
Description
Cranial Fixation System FDA UDI

Identifiers

Primary DI / UDI-DI
18437006085042 FDA UDI
510(k) Number
K132044 FDA UDI
FDA Product Code
GXR FDA UDI
GMDN Term
Cranial bur hole cover FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5250 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

Category: Cranial bur hole cover

Cranial LOOP by Neos Surgery Sl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cranial bur hole cover.

Cleared under the same submission

K132044 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neos Surgery Sl

Sources (1)

  • FDA UDI 7ded4938-0c7f-4805-a250-c9b981e4334d 35 fields · synced May 30, 2026