AccessGUDID - DEVICE: Safco One Sheet Tray Covers (D72310261583)

GUDID

Device Identifier (DI) Information

Brand Name: Safco One Sheet Tray Covers
Version or Model: 1026158
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1026158
Company Name: SAFCO DENTAL SUPPLY CO.

Primary DI Number: D72310261583
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1000
Labeler D-U-N-S® Number*: 020417380 *Terms of Use

Device Description: Safco One Sheet tray covers, blue, 1,000/box

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?
64367	Instrument tray cover, single-use	A flexible, synthetic polymer cover designed to be placed on an instrument tray to provide a protective barrier for the transport and short-term storage of clinical instruments (typically endoscopes or surgical instruments). It is typically available in two colours to indicate clean/sterile or contaminated; a tray liner is typically supplied with the device. 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: ad9aa9b9-a888-43e6-82cb-ace7927fa9e5
Public Version Date: December 20, 2022
Public Version Number: 1
DI Record Publish Date: December 12, 2022