AccessGUDID - DEVICE: ExoShield (00860002676401)

GUDID

Device Identifier (DI) Information

Brand Name: ExoShield
Version or Model: 40010548
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 40010548
Company Name: NORTHSTAR MEDICAL RADIOISOTOPES, LLC

Primary DI Number: 00860002676401
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 025677872 *Terms of Use

Device Description: External lead shielding

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):	No
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?
38374	Radiation shielding panel, fixed	A permanently installed device forming a structural barrier designed to block or attenuate radiation emissions from a primary or scattered radiation source. It includes various solid or transparent barriers typically used to shield patients from unnecessary exposure to radiation emitted from, e.g., diagnostic/therapeutic radiation emitting devices. It may also be used to shield a patient undergoing a diagnostic or therapeutic procedure requiring the administration of a radioactive material or placement of a radioactive source. The barrier can be permanently attached to the floor, wall or ceiling or to a medical device, or mounted on articulating structures giving a limited range of motion.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EAK	Screen, Leaded, Operator Radiation Protector

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

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 Record Status

Public Device Record Key: 0ad6aed4-4ae4-4481-8a73-5d3a154443ef
Public Version Date: January 15, 2020
Public Version Number: 1
DI Record Publish Date: January 07, 2020