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

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 04250435501573
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 313517922 *Terms of Use

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

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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 intended to hold the head and neck in a particular fixed position during surgical procedures. It is connected to the skull with screws or pins (not included), typically on each side of the forehead, whilst the other end is fixed to an operating table or chair. Commonly known as a Mayfield skull clamp, it is made of metal materials (non-radiolucent) and may have adjustable joints to allow variable head positioning; it is 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 intended to hold the head and neck in a particular fixed position during surgical procedures. It is connected to the skull with screws or pins (not included), typically on each side of the forehead, whilst the other end is fixed to an operating table or chair. Commonly known as a Mayfield skull clamp, it is made of metal materials (non-radiolucent) and may have adjustable joints to allow variable head positioning; it is not intended for applying traction forces to the cervical spine. This is a reusable device.

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K001808	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3f7675c0-5641-49b3-9e46-e90661facbdb
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 15, 2016