AccessGUDID - DEVICE: Unipack (D784UBC85508S1)

GUDID

Device Identifier (DI) Information

Brand Name: Unipack
Version or Model: UBC-85508S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: UBC-85508S
Company Name: UNIPACK MEDICAL CORPORATION

Primary DI Number: D784UBC85508S1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 72
Labeler D-U-N-S® Number*: 018319397 *Terms of Use

Device Description: Saliva Ejector Screens 85508S Universal Fit

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):	Yes
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?
65060	Dental suction system in-line filter	A screening device designed to be fitted in the suction line of a dental suction system (e.g., in the saliva ejector valve) to trap debris [e.g., amalgam, bone particles, dentin/enamel particles] and stop them from entering the mains drainage system during a dental procedure. It is in the form of cylindrical/conical flange with numerous small openings. The device is not intended to be used as a dedicated autologous bone particle collector. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHZ	Evacuator, oral cavity

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: ff965d71-766d-4d15-aec2-fa785237185c
Public Version Date: December 14, 2022
Public Version Number: 1
DI Record Publish Date: December 06, 2022