Mayfield®

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name: MAYFIELD® FDA UDI
Generic Name: Skull clamp FDA UDI
Device Name: MAYFIELD MR SKULL PIN STARTER KIT (E8806FA) FDA UDI
Model / Reference: A2021 FDA UDI
Description: MAYFIELD MR SKULL PIN STARTER KIT (E8806FA) FDA UDI

Identifiers

Primary DI / UDI-DI: 10381780253754 FDA UDI
FDA Product Code: HBL FDA UDI
GMDN Term: Skull clamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4460 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Skull clamp

Mayfield® by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skull clamp.

DORO® Base Unit — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · Class II
DORO® Skull Clamp System — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · Class II
ClearPoint — Clearpoint Neuro, Inc. · Class II
DORO® pin holder — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · Class II
DORO® Quick-Clamp — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · Class II
V. Mueller — STERIS CORPORATION · Class II
ClearPoint — Clearpoint Neuro, Inc. · Class II
DORO® Base Unit Radiolucent — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · 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

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Manufacturer

Manufacturer: Integra Lifesciences Corp.

Sources (1)

FDA UDI 8ca3ba1e-cccc-4d2e-b045-4a5f5c24487c 34 fields · synced May 30, 2026