AccessGUDID - DEVICE: DORO® Skull Clamp System (04250435501573)

GUDID

Device Identifier (DI) Information

Brand Name: DORO® Skull Clamp System
Version or Model: 3020-00
Catalog Number:
Company Name: pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Primary DI Number: 04250435501573
Issuing Agency: GS1
Device Count: 1

Device Description: DORO® Multi-Purpose Skull Clamp System, consisting of: 3006-10 3020-01 3020-03 3020-50 3020-55 3020-61 3020-62 3020-63 3020-65 3020-68 3020-71 3020-001

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Skull clamp	A U-shaped surgical device that is attached to the skull to hold the head and neck in a particular fixed position during surgical procedures. Pointed screws are extended from this device and screwed into the patient's skull, typically one on either side of the forehead whilst the other end is fixed to an operating table or chair where the patient is correctly positioned. It is commonly known as a Mayfield skull clamp, and typical applications include neurosurgical procedures. It is made of metal materials (non-radiolucent) with adjustable joints to allow variable head positioning and is generally not intended for applying traction forces to the cervical spine. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Skull clamp

A U-shaped surgical device that is attached to the skull to hold the head and neck in a particular fixed position during surgical procedures. Pointed screws are extended from this device and screwed into the patient's skull, typically one on either side of the forehead whilst the other end is fixed to an operating table or chair where the patient is correctly positioned. It is commonly known as a Mayfield skull clamp, and typical applications include neurosurgical procedures. It is made of metal materials (non-radiolucent) with adjustable joints to allow variable head positioning and is generally not intended for applying traction forces to the cervical spine. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
HBL	Holder, Head, Neurosurgical (Skull Clamp)

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: December 15, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES

DEVICE: DORO® Skull Clamp System (04250435501573)