AccessGUDID - DEVICE: Dummy, silver, type COE (04049223104887)

GUDID

Device Identifier (DI) Information

Brand Name: Dummy, silver, type COE
Version or Model: AGD.A31
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AGD.A31
Company Name: Eckert & Ziegler BEBIG GmbH

Primary DI Number: 04049223104887
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 331080432 *Terms of Use

Device Description: No description.

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:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38304	Manual brachytherapy source, temporary placement	A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope in a form that is intended for temporary placement in the body and removal after a specified treatment time. It is used in brachytherapy applications that require direct manual or endoscopically-guided placement and removal. Manually inserted sources intended for temporary placement come in a variety of forms, e.g., encapsulated, sealed, plated, foil or embedded sources. It can be inserted directly into the patient or be implanted using catheters or applicators and may take the form of needles, spheres, ovoids, seeds, wires or liquids included in the cuffed portion of a catheter.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXK	Source, Brachytherapy, Radionuclide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K931393	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a clean, dry environment (relative humidity < 95%). Make sure that the packaging is not damaged, and that no chemicals are in close proximity to the storage location.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6ad562aa-1f4b-456b-a7ba-990dc8b1e883
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 25, 2015