AccessGUDID - DEVICE: Ultracell® (30886158014783)

GUDID

Device Identifier (DI) Information

Brand Name: Ultracell®
Version or Model: SM-NS30305-C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SM-NS30305-C
Company Name: Beaver-Visitec International, Inc.

Primary DI Number: 30886158014783
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001406024 *Terms of Use

Device Description: ***NON-STERILE*** SHIPPERT MED FENESTRATED EAR WICK, 9MM DIA X 15MM (250/SP)

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?
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 [?]
K920357	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
Special Storage Condition, Specify: Store in a dry place.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7ce7c128-2c6b-4cca-af2a-66ae9b28b492
Public Version Date: June 14, 2024
Public Version Number: 1
DI Record Publish Date: June 06, 2024