AccessGUDID - DEVICE: NETCELL (05060165010387)

GUDID

Device Identifier (DI) Information

Brand Name: NETCELL
Version or Model: 30-310
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NETWORK MEDICAL PRODUCTS LIMITED

Primary DI Number: 05060165010387
Issuing Agency: GS1
Commercial Distribution End Date: October 08, 2024
Device Count: 10
Labeler D-U-N-S® Number*: 458670304 *Terms of Use

Device Description: NETCELL 24mm Ear Wick

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:	Yes
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?
33468	Ear wick, non-biodegradable	A non-biodegradable packing material [e.g., loosely twisted unspun cotton, gauze, or polyvinyl alcohol (PVA)] intended to be used in the ear of a patient after internal ear surgery, and/or to administer medicinal substances to the ear to treat ear disorders. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCN	Ear Wick

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: Yes
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: cb5162a9-5de0-4467-8b21-cee90cc10d22
Public Version Date: October 09, 2024
Public Version Number: 2
DI Record Publish Date: August 06, 2019