AccessGUDID - DEVICE: Safco Chloroprene Green (D72310280743)

GUDID

Device Identifier (DI) Information

Brand Name: Safco Chloroprene Green
Version or Model: 1028074
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1028074
Company Name: SAFCO DENTAL SUPPLY CO.

Primary DI Number: D72310280743
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 020417380 *Terms of Use

Device Description: Safco Chloroprene Green small 100bx

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?
10098	Ampule opener	A cutting instrument intended to safely remove/break the protective, sterile seal of an ampule. It is typically designed to protect the user from inadvertent contact with the sharp edges of the seal while being removed. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZA	Polymer patient examination glove

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cf59a68e-0846-434b-b5f8-ea0bf05991c0
Public Version Date: January 10, 2023
Public Version Number: 2
DI Record Publish Date: July 18, 2018