AccessGUDID - DEVICE: Extend Frame system (07340048305556)

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Device Identifier (DI) Information

Brand Name: Extend Frame system
Version or Model: 1526874
Catalog Number:
Company Name: Elekta Instrument AB

Primary DI Number: 07340048305556
Issuing Agency: GS1
Device Count: 1

Device Description: EXTEND MOUTH PIECE S P2 (1PCS)

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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
Teletherapy radionuclide system	An assembly of devices that deliver a therapeutic radiation dose to an anatomical region from a single external radiation beam produced by a radionuclide source. A typical system is: 1) the treatment head (a shielded source vault containing a single radioactive source located in a moveable housing); 2) a rotating or fixed gantry with the treatment head at one end and a counter weight functioning as a beam stop on the other; 3) a collimator mechanism attached to the gantry to align the treatment beam; 4) a moveable patient table used to align and position the patient in the radiation beam; and 5) an operator's console containing the controls. It is commonly known as a cobalt therapy machine.

GMDN Preferred Term Name

GMDN Definition

Teletherapy radionuclide system

An assembly of devices that deliver a therapeutic radiation dose to an anatomical region from a single external radiation beam produced by a radionuclide source. A typical system is: 1) the treatment head (a shielded source vault containing a single radioactive source located in a moveable housing); 2) a rotating or fixed gantry with the treatment head at one end and a counter weight functioning as a beam stop on the other; 3) a collimator mechanism attached to the gantry to align the treatment beam; 4) a moveable patient table used to align and position the patient in the radiation beam; and 5) an operator's console containing the controls. It is commonly known as a cobalt therapy machine.

FDA Product Code

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Product Code	Product Code Name
IWB	System, radiation therapy, radionuclide

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

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Size Type Text
No Device Sizes

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 24, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

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

Secondary DI

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

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DEVICE: Extend Frame system (07340048305556)