AccessGUDID - DEVICE: Safco Contour 4-ply fitted bibs (D72322161773)

GUDID

Device Identifier (DI) Information

Brand Name: Safco Contour 4-ply fitted bibs
Version or Model: 2216177
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2216177
Company Name: SAFCO DENTAL SUPPLY CO.

Primary DI Number: D72322161773
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 400
Labeler D-U-N-S® Number*: 020417380 *Terms of Use

Device Description: Safco Contour bib 18x22 grn 400/case

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?
61050	Dental bib	A non-sterile device intended to be worn by a patient during a dental examination or treatment procedure to function as a barrier to soiling and cross-contamination. It typically consists of a shaped piece of natural and/or synthetic material intended to be fastened around the neck and cover the front side of the upper body. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KHR	ABSORBER, SALIVA, PAPER

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: 7d32df75-8a6e-4d80-a304-2c2dce4aa3ed
Public Version Date: December 10, 2021
Public Version Number: 1
DI Record Publish Date: December 02, 2021