AccessGUDID - DEVICE: Zipshield 5m (00850011306963)

GUDID

Device Identifier (DI) Information

Brand Name: Zipshield 5m
Version or Model: 5m
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 31-0604-0128
Company Name: NEURALYNX, INC.

Primary DI Number: 00850011306963
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 933200842 *Terms of Use

Device Description: This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily applied over one or more ATLAS Tether cables providing both noise shielding and cable management.

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?
38370	Facility radio-frequency shielding material	A radiation protection device consisting of electrically conductive materials used in conjunction with other medical devices in a medical facility to form a barrier against radio-frequency (RF) emissions and interference. This kind of material protects medical devices and/or persons from incident or stray radio-frequency fields. This group of devices includes a wide variety of materials, e.g., copper (Cu) sheeting and copper mesh. Copper sheets and copper mesh are used in walls, floors, ceiling, doors and windows for magnetic resonance imaging rooms to prevent interference with the electronics used to form and receive the radio-frequency imaging pulses.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OMC	Reduced- Montage Standard Electroencephalograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110967	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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 015932db-c4ff-467a-a099-0352ce01faa7
Public Version Date: December 19, 2024
Public Version Number: 1
DI Record Publish Date: December 11, 2024