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: The MAYFIELD® Skull Clamp is placed on the patient’s skull to hold their head and neck in a particular position when rigid fixation is desired. The skull clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. The accessories provided with the skull clamp also allow it to be used where stabilization is desired instead of complete fixation FDA UDI
Model / Reference: A1108SRL FDA UDI
Description: The MAYFIELD® Skull Clamp is placed on the patient’s skull to hold their head and neck in a particular position when rigid fixation is desired. The skull clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. The accessories provided with the skull clamp also allow it to be used where stabilization is desired instead of complete fixation FDA UDI

Identifiers

Primary DI / UDI-DI: 10381780253532 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

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe 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 511bab61-3c49-4c2a-b987-980cad7ded12 35 fields · synced Jun 8, 2026