AccessGUDID - DEVICE: Safco Irrigating Syringes (D72310200923)

GUDID

Device Identifier (DI) Information

Brand Name: Safco Irrigating Syringes
Version or Model: 1020092
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1020092
Company Name: SAFCO DENTAL SUPPLY CO.

Primary DI Number: D72310200923
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 020417380 *Terms of Use

Device Description: Safco irrigating syringe, Luer lock hub style, 3cc syringe, 100/bag

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?
35390	Irrigation syringe	A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIB	Syringe, irrigating (dental)

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: Yes
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: 89bed8b1-5727-479a-bcfc-a9240b80bad2
Public Version Date: November 29, 2022
Public Version Number: 1
DI Record Publish Date: November 21, 2022