AccessGUDID - DEVICE: Ultracell® (30886158013281)

GUDID

Device Identifier (DI) Information

Brand Name: Ultracell®
Version or Model: SS10111-CT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SS10111-CT
Company Name: Beaver-Visitec International, Inc.

Primary DI Number: 30886158013281
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001406024 *Terms of Use

Device Description: ***NON-STERILE*** NETWORK NASAL PACK WITH TUBE, 8CM (500/SP) (SUPPLIED NON-STERILE)

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?
46941	ENT space-occupying dressing, human-derived	A sterile, bioabsorbable material intended to be used to help heal tissue, limit adhesions between mucosal surfaces, and control bleeding after ear/nose/throat (ENT) surgery. It is typically available as gel or gelatin sponge of human tissue origin. In nasal/sinus applications it may be aspirated (removed) from the cavity before absorption.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
EMX	BALLOON, EPISTAXIS

FDA Premarket Submission

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

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: b07d9cad-03ac-4c9b-b13d-a1b6d2f791a6
Public Version Date: July 05, 2024
Public Version Number: 1
DI Record Publish Date: June 27, 2024